The purpose of this Phase III study is to evaluate the efficacy and safety of Alzhemed™ compared to placebo (inactive substance pill) in patients with mild to moderate Alzheimer’s disease.

Condition	Treatment or Intervention	Phase
Alzheimer Disease	Drug: Alzhemed™	Phase III

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Patients may be included in this study if they meet all of the following criteria:

• Male or Female (age 50 years and older): Female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal).
• Diagnosis of probable Alzheimer’s disease based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA criteria).
• Severity of dementia of mild to moderate degree as assessed by the Mini Mental State Examination (MMSE) performed at the screening visit.
• Patient must be living in the community with a reliable caregiver. Participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver.
• Potential participant must be treated with conventional Alzheimer’s disease therapies and must be on stable dose for at least 4 months prior to the screening visit and during the entire study period.
• Fluency in English, French or Spanish (oral and written).
• Signed informed consent from potential participant or legal representative and caregiver.

Exclusion Criteria:

Patients will not be eligible to participate in the study if they meet any of the following criteria:

• Potential participant with any other cause of dementia.
• Life expectancy less than 2 years.
• Potential participant with a clinically significant and/or uncontrolled condition or other significant medical disease.
• Use of an investigational drug within 30 days prior to the screening visit or during the entire study.
• Previous use of Alzhemed™.

For general information on this trial:       pic@neurochem.com
Other locations will be listed upon availability.    

Arizona
      Pivotal Research Centers, Peoria,  Arizona,  United States; Recruiting
      21st Century Neurology, a division of Xenoscience, Phoenix,  Arizona,  United States; Not yet recruiting
Arkansas
      Central Arkansas Research, Hot Springs,  Arkansas,  United States; Not yet recruiting
California
      Margolin Brain Institute, Fresno,  California,  United States; Recruiting
      Pacific Research Network, Inc., San Diego,  California,  United States; Recruiting
      Senior Clinical Trials, Inc., Laguna Hills,  California,  United States; Recruiting
      San Francisco Clinical Research Center, San Francisco,  California,  United States; Recruiting
Colorado
      Radiant Research, Denver,  Colorado,  United States; Recruiting
Connecticut
      Yale University, Alzheimer's Disesase Research Unit, New Haven,  Connecticut,  United States; Recruiting
      Research Center for Clinical Studies, Inc., Darien,  Connecticut,  06820,  United States; Recruiting
      New England Research Institute, Stamford,  Connecticut,  United States; Recruiting
District of Columbia
      Georgetown University Medical Center, Washington,  District of Columbia,  United States; Recruiting
Florida
      Berma Research Group, Hialeah,  Florida,  United States; Recruiting
      Stedman Clinical Trials, Tampa,  Florida,  United States; Recruiting
      Tukoi Institute for Clinical Research, Miami,  Florida,  United States; Recruiting
      Palm Beach Neurological Center, Palm Beach Gardens,  Florida,  United States; Recruiting
      Premiere Research Institute Palm Beach Neurology, West Palm Beach,  Florida,  United States; Recruiting
      Axiom Clinical Research, Tampa,  Florida,  United States; Recruiting
      Neuropsychiatric Research Center of SouthWest Florida, Fort Myers,  Florida,  United States; Not yet recruiting
      Byrd Alzheimer’s Center and Research Institute, Tampa,  Florida,  United States; Recruiting
      Quantum Laboratories Inc at the Memory Disorders Clinic, North Broward Medical Center, Pompano Beach,  Florida,  United States; Recruiting
      University of South Florida, Suncoast Gerontology Center, Tampa,  Florida,  United States; Recruiting
Georgia
      Emory University, Atlanta,  Georgia,  United States; Recruiting
Illinois
      Southern Illinois University (SIU) School of Medicine, Department of Neurology, Springfield,  Illinois,  United States; Recruiting
Massachusetts
      Brigham & Women's Hospital, Boston,  Massachusetts,  United States; Recruiting
New Jersey
      Memory Enhancement Center, Long Branch,  New Jersey,  United States; Recruiting
New York
      Neurological Associates of Albany, Albany,  New York,  United States; Recruiting
      Global Research and Consulting, Olean,  New York,  United States; Not yet recruiting
      Eastside Comprehensive Medical Center, New York,  New York,  United States; Recruiting
      NYU School of Medicine, New York,  New York,  United States; Recruiting
North Carolina
      Richard H. Weisler, MD, PA and Associates, Raleigh,  North Carolina,  United States; Recruiting
      Wake Forest University School of Medicine, Department of Psychiatry and Behavioral Medicine, Winston Salem,  North Carolina,  United States; Recruiting
Ohio
      Neurology and Neuroscience Center of Ohio, Toledo,  Ohio,  United States; Recruiting
Oklahoma
      Clinical Pharmaceuticals Trials, Inc., Tulsa,  Oklahoma,  United States; Recruiting
Pennsylvania
      CNS Research Institute, Philadelphia,  Pennsylvania,  United States; Recruiting
      Farber Institute for Neurosciences, Philadelphia,  Pennsylvania,  United States; Not yet recruiting
Rhode Island
      CNS Research, Inc., East Providence,  Rhode Island,  United States; Recruiting
      Memory and Aging Program, Butler Hospital, Providence,  Rhode Island,  United States; Recruiting
South Carolina
      MUSC - Alzheimer's Research and Clinical Programs, North Charleston,  South Carolina,  United States; Recruiting
Tennessee
      Clinical Research Services at Tennessee Christian Medical Center, Madison,  Tennessee,  United States; Recruiting
Vermont
      The Memory Clinic, Bennington,  Vermont,  United States; Recruiting
Canada, Alberta
      Glenrose Rehabilitation Hospital, Edmonton,  Alberta,  Canada; Not yet recruiting
Canada, British Columbia
      The Medical Arts Health Research Group, a Division of PCT Networks, Inc., Penticton,  British Columbia,  Canada; Recruiting
Canada, Nova Scotia
      Queen Elizabeth II Health Sciences Centre, Halifax,  Nova Scotia,  Canada; Not yet recruiting
Canada, Ontario
      Gerontion Research, Toronto,  Ontario,  Canada; Not yet recruiting
      Geriatric Clinical Trials Group, Parkwood Hospital, London,  Ontario,  Canada; Not yet recruiting
      Toronto Memory Program, Toronto,  Ontario,  Canada; Recruiting
Canada, Quebec
      Memory & Motor Skills Disorders Clinic, Ville de Québec,  Quebec,  Canada; Recruiting
      Centre de recherche Novabyss, Sherbrooke,  Quebec,  Canada; Recruiting
      Clinique Neuro Rive-Sud, Greenfield Park,  Quebec,  Canada; Recruiting
      Hôpital Maisonneuve-Rosemont, Recherche Clinique de Neurologie, Montreal,  Quebec,  Canada; Not yet recruiting

Study ID Numbers:  CL-758007
Record last reviewed:  November 2004
Record first received:  July 30, 2004
ClinicalTrials.gov Identifier:  NCT00088673
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10