A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

The purpose of this study is to determine whether alpha-tocopherol, memantine (Namenda), or the combination will significantly delay clinical progression in mild to moderately demented patients with Alzheimer's disease compared to placebo.

Key facts

Study ID

NCT00235716

Run by

US Department of Veterans Affairs

People needed

613

Starts

2007-08-01

Expected to finish

2012-10-01

Last updated by the study team

2014-07-23

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• VA Medical Center, Bay Pines — Bay Pines, Florida, United States
• VA Medical Center, Miami — Miami, Florida, United States
• VA Medical Center, Iowa City — Iowa City, Iowa, United States
• VA Maryland Health Care System, Baltimore — Baltimore, Maryland, United States
• VA Medical Center, Jamaica Plain Campus — Boston, Massachusetts, United States
• VA Ann Arbor Healthcare System — Ann Arbor, Michigan, United States
• VA Medical Center, Minneapolis — Minneapolis, Minnesota, United States
• Salisbury VAMC — Salisbury, North Carolina, United States
• VA Medical Center, Cleveland — Cleveland, Ohio, United States
• Ralph H Johnson VA Medical Center, Charleston — Charleston, South Carolina, United States
• VA North Texas Health Care System, Dallas — Dallas, Texas, United States
• VA Puget Sound Health Care System, Seattle — Seattle, Washington, United States
• Wlliam S. Middleton Memorial Veterans Hospital, Madison — Madison, Wisconsin, United States
• VA Medical Center, San Juan — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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