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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Collaborators: DSM Nutritional Products, Inc.; Forest Laboratories
• Treatments: alpha-Tocopherol; Memantine; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

Inclusion Criteria:

1. Diagnoses of possible or probable Alzheimer's disease (NINCDS-ADRDA)

2. 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

3. Written informed consent from both the patient (or surrogate) and caregiver

4. An MMSE score between 12 and 26 inclusive

5. 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

6. 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:

1. A non-Alzheimer primary dementia (e.g., vascular dementia, Lewy body dementia, fronto-temporal dementia, vitamin B-12 deficiency, hypothyroidism)

2. Current major depression, delirium, alcohol or psychoactive substance abuse or dependency, schizophrenia, or delusional disorder as defined by DSM-IV

3. Presence of any uncontrolled systemic illness that would interfere with participation in the study or a life expectancy of less than one year

4. Pregnant or intention to become pregnant

5. Enrollment in another interventional clinical trial

6. Current prescription with more than one AChE inhibitor

7. Current prescription for warfarin

8. Use of vitamin E supplements in the past 2 weeks

9. Use of memantine in the past 4 weeks or known intolerance

10. Estimated creatinine clearance less than 5ml/min (Cockcroft-Gault formula)

11. Use of amantadine in the past 2 weeks