Phase 3 Completed N=613 Randomized Quadruple-blind Treatment

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

Alzheimer's Disease

Source: ClinicalTrials.gov NCT00235716 ↗

Enrolled (actual)

613

Serious AEs

56.1%

Results posted

Jan 2014

Primary outcomePrimary: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline — -1.72; -2.40; -2.78; -4.52 units on a scale — p=0.03

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline	-1.72; -2.40; -2.78; -4.52; -4.29; -6.99	0.03 sig
PRIMARY Mini-Mental State Examination Change From Baseline	-0.35; -0.24; -0.20; -0.34; -0.95; -1.09	0.84
PRIMARY Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline	1.38; 1.11; 1.53; 3.04; 2.40; 3.32	0.10
PRIMARY Neuropsychiatric Inventory Change From Baseline	-1.24; -0.20; -0.47; 0.46; -1.04; 0.31	0.94
PRIMARY Caregiver Activity Survey Change From Baseline	-0.93; 0.99; 1.08; 1.20; -0.18; 2.72	0.12
SECONDARY Dependence Scale: Time to Event Analysis (Increase of of One Dependence Level)	80; 87; 87; 79	0.69

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00235716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.