Dr. Mark Brody's (CV)

Curriculum Vitae

Education and Training:

U.C.S.D. Medical Center, San Diego, California
Cerebrovascular Vascular Fellow, Headache Fellow, 1991 – 1992

U.C.S.D. Medical Center, San Diego, California
Senior Assistant Neurologist Residency, 1989 – 1991

Harbor U.C.L.A. Medical Center, Torrance, California
Junior Assistant Neurologist Residency, 1988 – 1989

Akron General Hospital, Akron, Ohio
Internal Medicine Residency PGYI, 1987 – 1988

Foothills Hospital, Calgary, Alberta, Canada
General Surgery Residency, 1981 – 1983

Victoria Hospital, London, Ontario, Canada
Rotating internship, 1979 – 1980

University of Calgary Medical School, Calgary, Alberta, Canada
Doctor of Medicine, 1976-1979

University of Western Ontario, London, Ontario, Canada
Bachelor of Science, 1972-1975

Employment History / Academic Positions:

1997 ~ Present Brain Matters, Inc., Boynton Beach, FL
PRIVATE PRACTICE NEUROLOGIST / CEO

1997 ~ 2010 Bethesda Memorial Hospital, Boynton Beach, FL
MEDICAL DIRECTOR COMPREHENSIVE STROKE PROGRAM

1996 ~ 1997 Neurologic Consultants, Pompano Beach, FL
PRIVATE PRACTICE NEUROLOGIST

1996 ~ 1997 North Broward Medical Center, Pompano Beach, FL
DIRECTOR OF ACUTE INTERVENTIONAL STROKE PROGRAM

1995 ~ 1996 University of South Alabama Medical Center, Mobile, AL
ASSOCIATE PROFESSOR OF NEUROLOGY

1993 ~ 1995 Scripps Memorial Hospital, La Jolla and Encinitas, CA
DIRECTOR STROKE INVESTIGATIONAL RESEARCH PROGRAM

1993 ~ 1995 North County Neurology Associates, Scripps Memorial Hospital, La Jolla and Encinitas, CA
PRIVATE PRACTICE NEUROLOGIST

1992 ~ 1993 University of California, San Diego, CA
ASSISTANT CLINICAL PROFESSOR OF NEUROSCIENCES

1992 ~ 1993 V.A. Stroke Center, La Jolla, CA
CO-DIRECTOR
1992 ~ 1993 U.C.S.D. Experimental Headache Research Center, San Diego, CA
C0-DIRECTOR

1992 ~ 1993 U.C.S.D. Department of Neurosciences, San Diego, CA
CHAIRMAN QUALITY ASSURANCE COMMITTEE

1991 ~ 1993 U.C.S.D. Medical center, San Diego, CA
DIRECTOR NEUROSONOLOGY LAB / REPRESENTATIVE TO U.C.S.D. PATIENT REVIEW COMMITTEE

1985 ~ 1986 General Practice Locum Tenems, Fernie, British Columbia, Canada
GENERAL PRACTICE PHYSICIAN

1984 ~ 1985 General Practice Locum Tenems, Vancouver, British Columbia, Canada
GENERAL PRACTICE PHYSICIAN

Employment History / Academic Positions:

1997 ~ Present Brain Matters, Inc., Boynton Beach, FL
PRIVATE PRACTICE NEUROLOGIST / CEO

1997 ~ 2010 Bethesda Memorial Hospital, Boynton Beach, FL
MEDICAL DIRECTOR COMPREHENSIVE STROKE PROGRAM

1996 ~ 1997 Neurologic Consultants, Pompano Beach, FL
PRIVATE PRACTICE NEUROLOGIST

1996 ~ 1997 North Broward Medical Center, Pompano Beach, FL
DIRECTOR OF ACUTE INTERVENTIONAL STROKE PROGRAM

1995 ~ 1996 University of South Alabama Medical Center, Mobile, AL
ASSOCIATE PROFESSOR OF NEUROLOGY

1993 ~ 1995 Scripps Memorial Hospital, La Jolla and Encinitas, CA
DIRECTOR STROKE INVESTIGATIONAL RESEARCH PROGRAM

1993 ~ 1995 North County Neurology Associates, Scripps Memorial Hospital, La Jolla and Encinitas, CA
PRIVATE PRACTICE NEUROLOGIST

1992 ~ 1993 University of California, San Diego, CA
ASSISTANT CLINICAL PROFESSOR OF NEUROSCIENCES

1992 ~ 1993 V.A. Stroke Center, La Jolla, CA
CO-DIRECTOR
1992 ~ 1993 U.C.S.D. Experimental Headache Research Center, San Diego, CA
C0-DIRECTOR

1992 ~ 1993 U.C.S.D. Department of Neurosciences, San Diego, CA
CHAIRMAN QUALITY ASSURANCE COMMITTEE

1991 ~ 1993 U.C.S.D. Medical center, San Diego, CA
DIRECTOR NEUROSONOLOGY LAB / REPRESENTATIVE TO U.C.S.D. PATIENT REVIEW COMMITTEE

1985 ~ 1986 General Practice Locum Tenems, Fernie, British Columbia, Canada
GENERAL PRACTICE PHYSICIAN

1984 ~ 1985 General Practice Locum Tenems, Vancouver, British Columbia, Canada
GENERAL PRACTICE PHYSICIAN

Professional Licensure:

Active- Florida, Alabama, California

Inactive- Alberta, British Columbia, Ontario – Canada

Honors and Awards:

Government of Alberta Heritage Fund Bursary for Academic Excellence

Professional Memberships:

Academy of Clinical Research Professionals
Alzheimer’s Association
American Academy of Neurology
National Stroke Foundation
American Heart Association
National Brain Attack Coalition
Cerebrovascular Disease Council for the State of Florida
Drug Information Association
Society for Clinical Research Sites

Professional Memberships:

Academy of Clinical Research Professionals
Alzheimer’s Association
American Academy of Neurology
National Stroke Foundation
American Heart Association
National Brain Attack Coalition
Cerebrovascular Disease Council for the State of Florida
Drug Information Association
Society for Clinical Research Sites

Certifications:

CPI, Certified Physician Investigator
Academy of Clinical Research Professionals
GCP

Clinical Trial Experience:

2015 – Present A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects with Early Alzheimer’s Disease. Biogen MA, Inc. , Phase III.

2015 – Present A Randomized, Placebo Controlled, Parallel-Group, Double Blind Efficacy and Safety Trial of MK-8931 with a Long Term Double-Blind Extension in Subjects with Mild to Moderate Alzheimer’s Disease. Merck Sharp & Dohme Corp., Phase II-III.

2015 – Present Randomized, Double-Blind, Placebo Controlled, Multi-Center Registration Trial to Evaluate the Efficacy and Safety of TTP488 in Patient with Mild Alzheimer’s Disease Receiving Acetylcholinesterase Inhibitors and/or Memantine. TransTech Pharma, LLC, Phase III.

2015 – Present Phase 2a Feasibility Study of T3D-959 in Subjects with Mild-to-Moderate Alzheimer’s Disease. T3D Therapeutics, Phase IIa.

2015 – Present A Phase III, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Clinical Trial to Study the Efficacy and Safety of MK-8931 (SCH 900931) in Subjects with Amnestic Mild Cognitive Impairment Due to Alzheimer’s Disease (Prodromal AD). Merck Sharp & Dohme Corp., Phase III.

2015 – Present A Phase 1B, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Arm, Multiple-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous Crenezumab Administered in Patients with Mild to Moderate Alzheimer’s Disease. Genentech, Inc., Phase Ib.

2014 – Present A 24-month, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy, Safety, Tolerability, Biomarker, and Pharmacokinetic Study of AZD3293 in Early Alzheimer’s Disease. Astra Zeneca, Phase II-III.

2014 – Present A Double Blind, Randomized Placebo Controlled, Parallel Group Study to Simultaneously Qualify a Biomarker Algorithm for Prognosis of Risk of Developing Mild Cognitive Impairment due to Alzheimer’s Disease (MCI due to AD) and to Test the Safety and Efficacy of Pioglitazone (AD-4833 SR 0.8 mg QD) to Delay the Onset of MCI due to AD in Cognitively Normal Subjects. Takeda, Phase III.

2014 – Present A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Efficacy and Safety Study of Gantenerumab in Patients with Mild Alzheimer’s Disease. Hoffmann-La Roche, Phase III.

2014 – Present An Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia. TauRx Therapeutics, Phase III.

2014 – Present Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Month Trial of
Leuco-methylthionimium bis (hydromethanesulfonate) in Subjects with Mild Alzheimer’s Disease. TauRx Therapeutics, Phase III.

2013 – Present Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Month Trial of
Leuco-methylthionimium bis (hydromethanesulfonate) in Subjects with Mild to Moderate Alzheimer’s Disease. TauRx Therapeutics, Phase III.

2013 – Present A 26-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Investigate the Effects of Daily Administration of AC-1204 in Participants with Mild to Moderate Alzheimer’s Disease (AD) with an Optional 26-Week Open-label Extension. Accera, Inc., Phase II-III.

2013 – Present A Placebo-controlled, Double-Blind, Parallel-Group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer’s Disease. Eisai, Inc., Phase II.

2013 – Present Effect of Passive Immunization on the Progression of Mild Alzheimer’s Disease: Solanezumab (LY2062430) Versus Placebo. Eli Lilly, Phase III.

2013 – Present A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 26- Week, Phase 3 Study of Two Doses of EVP-6124 or Placebo in Subjects with Mild to Moderate Alzheimer’s Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication. EnVivo Pharmaceuticals, Inc., Phase III.

2013 – Present A Multicenter, Open-Label, Long-Term Safety Extension of Phase II Studies ABE4869g and ABE4955g in Patients with Mild to Moderate Alzheimer’s Disease. Genentech, Inc., Phase II.

2013 – 2015 Open Label, Crossover, Pilot Study to Assess the Efficacy and Safety of Perispinal Administration of etanercept (Enbrel ®) in Combination with Nutritional Supplements Versus Nutritional Supplements Alone in Subjects with Mild to Moderate Alzheimer’s Disease Receiving Standard Care. Life Extension, LLC, Phase I.

2014 A Two-Group, Observational Study to Assess the Relationship of the Functional Integrity of the Mammalian Target of Rapamycin (mTOR) Pathway in Peripheral Lymphocytes of Subjects with a Diagnosis of Mild Cognitive Impairment (MCI) with the Result of Amyloid Positron Emission Tomography (PET) imaging. Cytox, Observational.
2012 – 2014 A Randomized, 18-Week, Placebo-Controlled, Double-Blind, Parallel Group Study of the Safety and Efficacy of PF-05212377 (SAM-760) in Subjects With Mild-To-Moderate Alzheimer’s Disease with Existing Neuropsychiatric Symptoms on a Stable Daily Dose of Donepezil. Pfizer, Phase IIa.

2012 – 2015 A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Efficacy and Safety Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer’s Disease. Elan Pharmaceuticals, Inc., Phase II.

2012 – Present A 36-Week Safety Extension Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients with Moderate to Severe Alzheimer’s Disease. Elan Pharmaceuticals, Inc., Phase II.

2012 – Present A Randomized, Double-Blinded, Placebo-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB037 in Subjects with Prodromal or Mild Alzheimer’s Disease. Biogen, Phase Ib.

2012 – 2013 Assessment of Safety, Tolerability, and Pharmacodynamic Effects of LY2886721 in Patients with Mild Cognitive Impairment Due to Alzheimer’s Disease or Mild Alzheimer’s Disease. Eli Lilly, Phase Ib.

2012 – 2014 A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Effectiveness of Immune Globulin Intravenous (Human), 10% Solution (IGIV, 10%) for the Treatment of Mild to Moderate Alzheimer’s Disease (AD). Baxter, Phase III.

2012 – 2014 A Randomized, Double-Blind, Placebo- and Active-Controlled Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects with Mild to Moderate Alzheimer’s Disease. Abbott, Phase II.

2012 – 2014 A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer’s Disease on Stable Doses of Acetylcholinesterase Inhibitors. Abbott, Phase II.

2012 A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Mild to Moderate Alzheimer Disease Who Are Apolipoprotein E ε4 Non-Carriers. Wyeth, Phase III.

2012 – Present A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of RO4602522 Added to the Background therapy of the Acetylcholinesterase Inhibitors Donepezil or Rivastigmine in Patients with Moderate Severity Alzheimer’s Disease. Hoffmann-La Roche, Phase II.

2011 – 2012 A Randomized, Multi-center, Double-blind, Placebo and Active-controlled Cross-over Study of the Efficacy and Safety of BMS-954561 in patients with Diabetic Peripheral Neuropathic Pain (DPNP). Bristol-Myers Squibb, Phase II.

2011 –2012 A Randomized, Multi-center, Double-blind, Placebo and Active-controlled Cross-over Study of the Efficacy and Safety of BMS-954561 in patients with Post-herpetic Neuralgia (PHN). Bristol-Myers Squibb, Phase II.

2011 – Present Multi-center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the effect of Subcutaneous RO4909832 on Cognition and function in Prodromal Alzheimer’s Disease. Hoffmann-La Roche, Phase III.

2011 A Randomized, Double-Blind, Placebo-Controlled, Parallel, 24-Week, Phase 2 Study of Three Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) or Placebo in Subjects with Mild to Moderate Probable Alzheimer’s Disease. EnVivo Pharmaceuticals, Inc., Phase II.

2011 – 2012 A Multinational, Multi-center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of the effect on cognitive performance, safety, and tolerability of SAR110894D at the Dose of 0.5mg, 2mg, and 5mg/day for 24 weeks in patients with Mild to Moderate Alzheimer’s Disease on stable Donepezil therapy. Sanofi Aventis, Phase II.

2011 – 2013 A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center, Biomarker, Safety, and Pharmacokinetic Study of Bapineuzumab (AAB-001) Administered Subcutaneously at Monthly Intervals in Subjects with Mild to Moderate Alzheimer’s Disease. Janssen, Phase II.

2011 – 2014 A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-center, Phase II Study to evaluate the efficacy and safety of MABT5102A in Alzheimer’s Disease. Genentech, Inc. Phase II.

2011 – 2012 A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel–Group Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects with Mild to Moderate Alzheimer’s Disease Who Are Apolipoprotein E 4 Non-Carriers or a Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel–Group Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects with Mild to Moderate Alzheimer’s Disease Who Are Apolipoprotein E 4 Carriers. Wyeth, Phase III.

2011 – 2012 A Phase 3, Multi-center, Long term Safety and Tolerability Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects with Alzheimer’s Disease Who Are Apolipoprotein E 4 Carriers and Participated in Study 3133K1-3001-US. Wyeth, Phase III.

2010 – 2011 A 24 Week Open-Label Extension to study CENA713DUS44: A 24 Week, Prospective, randomized, Parallel-Group, Double-Blind, Multi-center Study Comparing the Effects of Rivastigmine Patch 15 cm² on Activities of Daily Living and Cognition in Patients with Severe Dementia of the Alzheimer’s Type (ACTION). Novartis, Phase IIIb.

2010 – 2011 An Open-Label Extension of the CONCERT Protocol (DIM 18) Evaluating Dimebon (Latrepirdine) in Patients with Alzheimer’s Disease. Medivation, Inc., Phase III.

2009 – 2012 A Phase 3 Extension, Multi-center, Double-Blind, Long Term Safety and Tolerability Treatment Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects with Alzheimer’s Disease who Participated in Study ELND115727-301 or in Study ELND115727-302. Janssen, Phase III.

2009 – 2010 A Phase 3 Multi-center, Randomized, Placebo-Controlled, Double-Blind Twelve-Month Safety and Efficacy Study Evaluating Dimebon in patients with Mild to Moderate Alzheimer’s Disease on Donepezil. Medivation, Phase III.

2009 – 2010 A Long-Term Follow-Up Study of Oral ELND005 (AZD-103) in Subject with Alzheimer’s Disease. Elan Pharmaceuticals, Inc., Phase II.

2009 – 2012 A Multi-center, Randomized, double-Blind, Placebo-Controlled Study of the Safety, Tolerability, pharmacodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients with Prodromal Alzheimer’s Disease. Bristol-Myers Squibb (BMS), Phase II.

2009 – 2011 A Phase 3, Multi-center, randomized, Double-Blind, placebo-Controlled, Parallel-Group Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Mild to Moderate Alzheimer’s Disease Who Are Apolipoprotein E 4 Carriers. Wyeth, Phase III.

2009 – 2011 A 24 Week Prospective, Randomized, Parallel-Group, Double-Blind, Multi-Center Study Comparing the Effects of Rivastigmine Patch 15 cm² vs. Rivastigmine Patch 5 cm² on Activities of daily Living and Cognition in Patients with Severe Dementia of the Alzheimer’s Type. Novartis, Phase IV.

2009 – 2011 An Open Label Study of the Safety and Tolerability of ST101 in Subjects with Alzheimer’s Disease. Sonexa Therapeutics, Inc., Phase II.
2009 – 2011 A Double-Blind, Placebo-Controlled Preliminary Study of efficacy, Safety and Tolerability of ST101 in the Treatment of Alzheimer’s Disease. Sonexa Therapeutics, Inc., Phase II.

2009 – 2011 A Double-Blind, Placebo-Controlled Preliminary Study of efficacy, Safety and Tolerability of ST101 in the Treatment of Alzheimer’s Disease in Subjects Concurrently Receiving Donepezil (Aricept®). Sonexa Therapeutics, Inc., Phase II.

2009 – 2010 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmocodynamic and Pharacokinetic Effects of BMS-708163 in the Treatment of Patients With Mild to Moderate Alzheimer’s Disease, Bristol-Myers Squibb, Phase II.

2009 – 2010 A Dose Ranging Randomized, Double-blind, Parallel-group Placebo-Controlled Multi-center Study of RO5313534 Used as Add-on to Donepezil Treatment in Patients with Mild to Moderate Symptoms of Alzheimer’s Disease. F. Hoffmann-La Roche Ltd., Phase II.

2009 – 2010 A Double-Blind, Randomized, Placebo-Controlled, Dose Escalating Study to Evaluate the Safety, Tolerability, and Immunogenicity of V950 Formulated on Aluminum-Containing Adjuvant with or without ISCOMATRIX™ in Patients with Alzheimer’s Disease. Merck & Co., Inc., Phase II.

2009 – 2009 Long-Term Safety and Tolerability of ABT-089 in Adults with Mild-to-Moderate Alzheimer’s Disease: An Open-Label Extension Study for Subjects Completing Study M06-876, Abbott Laboratories, Phase II.

2008 – 2010 A Multi-center, Open-Label, multiple Dose, Parallel Group Investigation of the Long-Term Safety, Tolerability, Reactogenicity in Subjects with Mild to Moderate Alzheimer’s Disease. Wyeth., Phase II.

2008 – 2010 A Multi-Center Phase I Study of the Safety and Tolerability of Dimebon in Alzheimer ’s Disease Patients on Memantine (Cohort 1), and Memantine Plus Donepezil (Cohort 2). Medivation, Phase I.

2008 – 2010 A Phase 2, 26-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of PRX-03140 in Subjects with Alzheimer’s Disease Receiving a Stable Dose of Donepezil. EPIX Pharmaceuticals, Phase II.

2008 – 2010 A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Tolerability Titration Study to Evaluate the Efficacy and Safety of Perampanel (E2007) in Patients with Post-Herpetic Neuralgia (PHN). Eisai. Phase II.

2008 – 2009 A Randomized, Double-Blind, Placebo-Controlled Study Using a Bayesian Adaptive Design to Evaluate the Efficacy and Safety of ABT-089 in Subjects With Mild-to-Moderate Alzheimer’s Disease on Stable Doses of Acetylcholinesterase Inhibitors. Abbott Laboratories, Phase II.

2007 – 2010 A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral ELND005 (AZD-103) in Alzheimer’s Disease. Elan Pharmaceuticals, Phase II.

2007 – 2008 A Phase III, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) in Patients with Mild to Moderate Alzheimer’s Disease who are Apolipoprotein E4 Carriers. Elan Pharmaceuticals, Phase III.

2007 – 2008 A Phase III, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) in Patients with Mild to Moderate Alzheimer’s Disease who are Apolipoprotein E4 Non-Carriers. Elan Pharmaceuticals, Phase III.

2007 – 2009 A Phase 2, 12-Week, Double Blind, Dose-Finding, Placebo-Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses (1 mg BID, 2 mg BID, 5 mg BID, and possibly 10 mg BID) in Subjects with Moderate to Severe Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesias. Schering-Plough, Phase II.

2007 – 2009 A 48-week, Multcenter, Randomized, Double-Blind, Parallel-Group Evaluation of the Comparitive Efficacy, Safety, and Tolerability of Exelon® 10 and 15 cm² patch in patients with Alzheimer’s Disease Showing Cognitive Decline during an Initial Open-Label Treatment Phase. Novartis, Phase IIIb.

2007 A Randomized-Withdrawal Phase III Study Evaluating the Safety and Efficacy of CG5503 Extended-Release (ER) in Subjects with Painful Diabetic Peripheral Neuropathy (DPN). Jonson and Johnson, Phase III.

2007 – 2009 An Open-Label Extension Study Evaluating the Safety and Tolerability of Memantine in Patients with Moderate to Severe Dementia of the Alzheimer’s Type. Forest, Phase III.

2007 – 2008 A Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics Trial of Multiple Ascending Fixed Doses of SAM-531 in Subjects with Mild to Moderate Alzheimer’s Disease. Wyeth, Phase IIa.

2007 – 2008 A Multicenter, Randomized, Double-Blind, Long-Term Extension Study to Determine the Safety, Tolerability, and Preliminary Long Term Efficacy of SRA-333 in Patients with Mild to Moderate Alzheimer’s Disease Treated with Cholinesterase Inhibitor. Wyeth, Phase II.

2007 – 2008 A Multicenter, Randomized, Double-Blind, Long-Term Extension Study to Determine the Safety, Tolerability, and Preliminary Long Term Efficacy of Lecozotan (SRA-333) SR in Patients with Mild to Moderate Alzheimer’s Disease. Wyeth, Phase II.

2007 – 2008 A Six Month Randomized, Double-Blind, Placebo-Controlled, Multicenter, Safety, Tolerability, and Efficacy Study of Three Doses of Lecozotan (SRA-333) SR in Outpatients with Mild to Moderate Alzheimer’s Disease Treated with a Cholinesterase Inhibitor. Wyeth, Phase II.

2007 – 2009 A 52-week open-label extension study of the long-term safety and efficacy of rosiglitazone extended-release (RSG XR) as adjunctive therapy to acetylcholinesterase inhibitors in subjects with mild-to-moderate Alzheimer’s disease (REFLECT-4). GlaxoSmithKline, Phase III.

2007 – 2009 A 54-week, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of rosiglitazone (extended release tablets) as adjunctive therapy to acetylcholinesterase inhibitors on cognition and overall clinical response in APOE ε4-stratified subjects with mild to moderate Alzheimer’s disease (REFLECT-3). GlaxosmithKline, Phase III.

2006 – 2009 Phase 3 Multinational, Randomized, Double Blind, Placebo Controlled Study of the Effect of Daily Treatment with MPC-7869 on Measures of cognition, Activities of Daily Living and Global Function in Subjects with Mild Dementia of the Alzheimer’s Type. Myriad, Phase III.

2007 – 2012 A Phase II, Multicenter, Open-Label, Long-Term, Treatment Study to Determine the Safety, Tolerability, and Efficacy of AAB-001 (ELN115727) in Patients with Alzheimer’s Disease who Participated in Study AAB-001-201, AAB-001-202, OR AAB-001-102. Elan, Phase II.

2007 – 2009 A Phase I, Randomized, Multi-center, Double-Blind, Placebo-Controlled, Single Ascending Dose, Safety, Tolerability, Reactogenicity, Pharmacokinetic, and Pharmacodynamic Study using AAB-001 Administered Subcutaneously in Patients with Mild to Moderate Alzheimer’s Disease. Elan, Phase I.

2007 – 2008 A Multi-centre, Open Label Extension Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson’s Disease Patients with Motor Fluctuations. Eisai, Phase III.

2007 – 2007 A Multicenter, Open-Label Study of the Safety and Efficacy of Long Term Use of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients with Postherpetic Neuralgia. Depomed, Phase III.

2006 – 2008 A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Patients with Moderate-to-Severe Dementia of the Alzheimer’s Type. Forest, Phase III.

2006 – 2008 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE ε4-stratified subjects with mild to moderate Alzheimer’s disease. Glaxo Smith Kline, Phase III.

2006 – 2009 A 54-week, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of rosiglitazone (extended release tablets) as adjunctive therapy to donepezil on cognition and overall clinical response in APOE ε4-stratified subjects with mild to moderate Alzheimer’s disease (REFLECT-2). Glaxo Smith Kline, Phase III.

2006 – 2009 A Longitudinal Study of Cognitive and Functional Abilities of Subjects with either Mild to Moderate Alzheimer’s disease, Mild Cognitive Impairment, or Normal Cognition Using A Neuropsychological Test Battery (NTB). Elan.

2006 – 2007 A Three-Month, Randomized, Double-Blind, Placebo- Controlled, Multicenter, Safety, Tolerability, and Efficacy Study of Three Doses of Lecozotan (SRA-333) SR in Outpatients with Mild to Moderate Alzheimer’s Disease with Donepezil as Active Control. Wyeth, Phase II.

2006 – 2007 A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson’s Disease Patients with Motor Fluctuations. Eisai, Phase III.

2006 – 2006 A Follow-up Study to Evaluate the Status of Patients who Participated in the Phase IIa Study AN1792 (QS-21)-201. Elan, Observational.

2006 – 2007 A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Explore the Safety and tolerability of Doses of E2007 Up to a Maximum of 6 mg In Patients with Parkinson’s Disease who Experience End-of dose – “Wearing Off” Motor Fluctuations. Eisai, Phase II.

2006 – 2007 A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients with Postherpetic Neuralgia. Depomed, Phase III.

2006 – 2008 A Randomized, Double-blind, Placebo-Controlled study To Evaluate the Effects of DHA on Cognitive Functions in the Elderly. Martek Biosciences.

2005 – 2006 A Double-Blind Placebo-Controlled Study of VP4896 for the Treatment of Mild-To-Moderate Alzheimer’s Disease. Voyager, Phase III.

2005 – 2007 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Safety And Efficacy Of MEM 1003 In Patients With Mild To Moderate Alzheimer’s Disease. Memory, Phase II.

2005 – 2006 A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients with Postherpetic Neuralgia. Depomed, Phase II.

2005 – 2007 A Prospective, Randomized, Double-Blind, Placebo-Controlled Single Bolus, Multinational, Multi-Center, Parallel Group, Dose Ranging Study of Desmoteplase (INN) in the Indication of Acute Stroke. Forest Research Institute, Phase III.

2005 – 2007 A Phase I, Multicenter, Randomized, Blinded, Single Ascending Dose, Safety, and Tolerability Trial of ACC-001(QS-21) in Patients with Mild to Moderate Alzheimer’s Disease. Elan, Phase I.

2005 – 2008 A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Immunogenicity Trial of AAB-001 (ELN116727) in Patients with Mild to Moderate Alzheimer’s Disease. Elan, Phase IIa.

2005 – 2006 An Open-Label Extension of a Double-Blind, Placebo-Controlled Study of Leuprolide Acetate Depot in the Treatment of Alzheimer’s Disease in Men. Voyager, Phase II.

2004 – 2006 A Double-Blind Placebo-Controlled Study of Leuprolide Acetate Depot in the Treatment of Alzheimer’s Disease in Men. Voyager, Phase II.

2004 – 2005 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Study of Efficacy and Safety of SGS742 in Subjects with Mild to Moderate Alzheimer’s Disease. Saegis, Phase II.

2003 – 2006 A Double-Blind, Randomized, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke. Astra-Zeneca, Phase IIb/III.

2002 – 2004 A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Effects of a Targeted Exposure of Intravenous Repinotan in Patients with Acute Ischemic Stroke. Bayer, Phase II.

2001 – 2002 A Randomized, Placebo-Controlled, Three Treatment Arm Study to
Determine the Safety and Efficacy of Argatroban Injection in Patients with Acute Ischemic Stroke. Texas Biotechnology Corporation, Phase II.

2000 – 2003 A Multicenter, Stratified, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Neurologic Function and Disability in Patients with Acute Ischemic Stroke Given Tissue Plasminogen Activator Plus YM872 or Tissue Plasminogen Activator Plus Placebo. Yamonouchi, Phase IIb.

2000 – 2003 A Randomized, Double-Blind, Placebo–Controlled Study to Evaluate Effects of YM872 on Lesion Volume as Measured By Diffusion, Perfusion and Flair Magnetic Resonance Imaging in Patients with Acute Ischemic Stroke. Yamonouchi, Phase IIb.

1999 – 2001 A Double – Blind, Placebo-Controlled, Safety, Efficacy and Dose Response Trial of Two IV Doses of BMS-204352 in Patients with Acute Stroke. Bristol Myers Squibb, Phase II.

1997 A Placebo-Controlled, Dose Ranging Safety and Tolerability Pilot Study of Remacemide Hydrochloride in Subjects with Probable Alzheimer’s Disease. Astra-Merck, Phase IIa.

1997 A Double – Blind, Placebo – Controlled Trial of TASMAR for the treatment of Parkinsons Disease. Roche, Phase III.

1996 A Randomized Trial of Tirilazad for the treatment of Acute Stroke.

1996 A Double – Blind, Placebo – Controlled Study to Determine the Efficacy of 500mg of Citicoline in Ischemic Stroke Patients.

1996 A Double – Blind, Placebo – Controlled Study of PrhNGF (Nerve Growth Factor) for the treatment of diabetic neuropathy. Genetech, Phase III.

1996 A Randomized Trial of Cervene (Baker Norton) for the treatment of Acute Ischemic Stroke.

1996 A Double – Blind, Placebo – Controlled Study of VML 251 for the treatment of Migraine Headaches. Vanguard.

1996 A Double – Blind, Placebo – Controlled Study of G.I.T.S. for the treatment of Alzheimer’s Disease. Parke-Davis, Phase II.

1996 – 1997 A Double – Blind, Placebo – Controlled Study of Zolmitriptan vs. Sumatriptan for the Treatment of Acute Migraine Headaches. AstraZeneca, Phase III.

1997 Multicenter, Open-Label Study of Safety and Tolerability of Metrifonate in Patients with Probable Alzheimer’s Disease. Bayer.

1997 Multicenter, double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Fixed-Dose Metrifonate Tablets in Patients with Probable Alzheimer’s Disease. Bayer.

1997 A Double – Blind, Placebo – Controlled Study of Metrifonate for the Treatment of Alzheimer’s
Disease. Bayer, Phase IIIb.

1996 – 1997 A Randomized Trial of Lubelozole for the treatment of Acute Ischemic Stroke. Janssen, Phase II.

1996 – 1997 A Randomized Trial of Cerestat for the treatment of Acute Ischemic Stroke. Boehringer, Phase II.

1996 Long-Term Treatment with Metrifonate for Patients with Alzheimer’s Disease. Bayer, Phase II.

1996 Open Pilot Study of BMY-21502 to Identify a Safe and Effective Dose Range for the Treatment of Symptoms of Mild Dementia of the Alzheimer’s Type. Bristol-Myers-Squibb.

1995 Mobile Community Stroke Data Bank, Funded by Alabama Heart Association.

1995 A Randomized Trial of Sulfotel for the Treatment of Acute Stroke.

1995 A Double – Blind, Placebo – Controlled Study of Warfarin for the Treatment of Recurring Strokes.

1994 A Double – Blind, Placebo – Controlled Study of Enlimomab Anti-ICAM for the Treatment of Ischemic Stroke.

1994 A Post-Marketing Sumatriptan Study for the Treatment of Migraine Headaches. Glaxo Smith Kline.

1993 – 1994 A Randomized Trial of Tirilazad for the treatment of an Acute Stroke.

1993 A Randomized Trial of Clopidogrel vs. Aspirin for Stroke Prevention.

1993 Monitoring of CSF neurotransmitter and T.C.D. monitoring of vascular reactivity in Acute Migraine Headaches.

1993 Clinically monitoring the treatment of CADAZINE in Perioperative Myocardial Infarction study.

1993 A Randomized Trial of Ancrod for the treatment of an Acute Stroke.

1992 An Open – Label Trial of Valproate For the treatment of Intractable Migraine or Chronic Daily Headache.

1992 Using Transcranial Doppler for Correlation in Clinical Stroke Syndromes.

1992 Using Transcranial Doppler for Predictive Value in Estimating Collateral Circulation and Subsequent Stroke Risk.

1991 Open Label Study of Tacrine in Alzheimer’s Disease: Patients with Prior Exposure to Tacrine. Warner Lambert Parke Davis.

1991 A Double – Blind, Placebo – Controlled Study to Determine the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Ascending Doses of Intravenous Dextrorphan HCI in Patients with Acute Stroke.

1990 – 1991 A Double – Blind, Placebo – Controlled Study of Ancrod for the treatment of an Acute Stroke.

1990 North American Symptomatic Carotid Endarterectomy Trial.

1990 – 1991 A Double-Blind Placebo-Controlled Multicenter Study of Tacrine in Alzheimer’s Disease. Warner Lambert Parke Davis.

1989 – 1990 A Double-blind, Placebo Controlled Parallel Group High Dose Study of Tacrine in Patients with Alzheimer’s Disease. Warner Lambert Parke Davis.

1990 NIH Tissue Plasminogen Activator Trial.

1990 – 1991 A Double – Blind, Placebo – Controlled Study of Ancrod for the treatment of an Acute Stroke.

1990 A Trial of ORG 10172 in Acute Stroke Treatment “PETT SCAN” investigation of artificially induced Parkinson’s Syndrome.

1990 A Asymptomatic Carotid Artery Stenosis study.

1990 A 12 Week, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response, Multicenter Study of CI-979 in Patients with Alzheimer’s Disease. Warner Lambert Parke Davis.

1990 A North American Symptomatic Carotid Endarterectomy Trial.

1990 A NIH Tissue Plasminogen Activator Trial.

1990 A Randomized Trial of ORG 10172 for the treatment of an Acute Stroke.

1986 – 1987 A”PETT SCAN” Investigation of Artificially Induced Parkinson’s Syndrome. University of British Columbia.

1974 – 1975 A Computer Model of Servo Feedback Loops in Motor Neuron Pathways.
University of Calgary Medical School.

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