A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease (TEAM-AD)
Alzheimer's Disease
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, clinical trial, randomized controlled trial, alpha-tocopherol, vitamin E, Namenda, memantine
Eligibility Criteria
Inclusion Criteria: Diagnoses of possible or probable Alzheimer's disease (NINCDS-ADRDA) Presence of a caregiver (friend or relative) who can assume responsibility for medication compliance, can accompany the patient to all visits, and rate patient's condition Written informed consent from both the patient (or surrogate) and caregiver An MMSE score between 12 and 26 inclusive Administration of a maintenance dosage of donepezil (5-10mg/d), rivastigmine (6-12mg/d) or rivastigmine (Exelon) patch (4.6 mg or 9.5 mg), galantamine or galantamine ER (16-24mg/d) for a minimum of 4 weeks prior to randomization Agreement not to take vitamin E supplements and/or memantine outside of the study (daily multivitamin is permitted containing up to 100 IU alpha-tocopherol) Exclusion Criteria: A non-Alzheimer primary dementia (e.g., vascular dementia, Lewy body dementia, fronto-temporal dementia, vitamin B-12 deficiency, hypothyroidism) Current major depression, delirium, alcohol or psychoactive substance abuse or dependency, schizophrenia, or delusional disorder as defined by DSM-IV Presence of any uncontrolled systemic illness that would interfere with participation in the study or a life expectancy of less than one year Pregnant or intention to become pregnant Enrollment in another interventional clinical trial Current prescription with more than one AChE inhibitor Current prescription for warfarin Use of vitamin E supplements in the past 2 weeks Use of memantine in the past 4 weeks or known intolerance Estimated creatinine clearance less than 5ml/min (Cockcroft-Gault formula) Use of amantadine in the past 2 weeks
Sites / Locations
- VA Medical Center, Bay Pines
- VA Medical Center, Miami
- VA Medical Center, Iowa City
- VA Maryland Health Care System, Baltimore
- VA Medical Center, Jamaica Plain Campus
- VA Ann Arbor Healthcare System
- VA Medical Center, Minneapolis
- Salisbury VAMC
- VA Medical Center, Cleveland
- Ralph H Johnson VA Medical Center, Charleston
- VA North Texas Health Care System, Dallas
- VA Puget Sound Health Care System, Seattle
- Wlliam S. Middleton Memorial Veterans Hospital, Madison
- VA Medical Center, San Juan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Arm 1
Arm 2
Arm 3
Arm 4
2,000 IU per day of dl-alpha-tocopherol plus placebo for memantine
20 mg per day of memantine plus placebo for dl-alpha-tocopherol
Combination of 2,000 IU per day of dl-alpha-tocopherol and 20 mg per day of memantine
Matching placebos for dl-alpha-tocopherol and memantine