At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of possible or probable Alzheimer's disease per NINCDS-ADRDA criteria
- ✓Presence of a caregiver who can ensure medication compliance, attend all visits, and assess patient status
- ✓MMSE score between 12 and 26 inclusive (mild-to-moderate cognitive impairment)
- ✓On stable maintenance cholinesterase inhibitor (donepezil 5–10 mg/d, rivastigmine 6–12 mg/d or patch 4.6–9.5 mg, or galantamine 16–24 mg/d) for ≥4 weeks prior to randomization
- ✕Non-Alzheimer's dementia (vascular, Lewy body, fronto-temporal, B12 deficiency, hypothyroidism)
- ✕Current major depression, delirium, alcohol or psychoactive substance abuse/dependency, schizophrenia, or delusional disorder (DSM-IV criteria)
- ✕Uncontrolled systemic illness that would interfere with study participation or life expectancy <1 year
- ✕Pregnant or intention to become pregnant
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CSP #546 - A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease (TEAM-AD)
In Brief
A Phase 3 clinical trial evaluating dl-alpha-tocopherol, Memantine, and 1 other intervention for Alzheimer's Disease. Completed, enrolled 613 participants across 14 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Alpha-tocopherol will be given as an oral dose of 1000 IU twice a day (morning and evening). The form of vitamin E that will be used in this study will be hard gel capsules of dl-alpha-tocopheryl acetate ("synthetic") vitamin E.
A moderate-affinity NMDA antagonist. Memantine will be titrated over four weeks to a maintenance dose of 10 mg twice a day. During week 1 patients will take one 5-mg memantine tablet in the morning. During week 2 patients will take one 5-mg memantine tablet in the morning and one in the evening. During week 3 patients will take two 5-mg memantine tablets in the morning and one 5-mg tablet in the evening. Beginning with week 4, participants will take four 5-mg tablets daily, two in the morning and two in the evening.
Alpha-tocopherol will be given as an oral dose of 1000 IU twice a day (morning and evening). The form of vitamin E that will be used in this study will be hard gel capsules of dl-alpha-tocopheryl acetate ("synthetic") vitamin E.
A moderate-affinity NMDA antagonist. Memantine will be titrated over four weeks to a maintenance dose of 10 mg twice a day. During week 1 patients will take one 5-mg memantine tablet in the morning. During week 2 patients will take one 5-mg memantine tablet in the morning and one in the evening. During week 3 patients will take two 5-mg memantine tablets in the morning and one 5-mg tablet in the evening. Beginning with week 4, participants will take four 5-mg tablets daily, two in the morning and two in the evening.
Matching placebos for dl-alpha-tocopherol and memantine.