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NCT00235716 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by US Department of Veterans Affairs.

Completed
Registry status
Phase 3
Development phase
613
Enrollment target

NCT00235716: Completed Phase 3 study, sponsored by US Department of Veterans Affairs.

NCT00235716 is a Phase 3 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 613 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00235716, a Phase 3 study, has completed, sponsored by US Department of Veterans Affairs.

COMPLETED
Registry status
Phase 3
Development phase
613 participants
Enrollment target

Study 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.

Primary Outcome

The primary outcome of the study was the Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory. The ADCS/ADL Inventory is designed to assess functional abilities to perform activities of daily living in Alzheimer patients with a broad range of dementia severity. The total score ranges from 0 to 78 with higher scores indicating greater abilities. Outcome analysis is average least square means change from baseline.

Interventions

  • DRUG Placebo
  • DRUG Memantine
  • DRUG dl-alpha-tocopherol

Trial Details

FieldValue
Enrollment Target 613 participants
Start Date 2007-08
Est. Completion 2012-10
Phase Phase 3
US Department of Veterans Affairs

632 total trials

What the finished NCT00235716 record still lists

NCT00235716 is an interventional study that assigns participants to a tested intervention. The registered 613 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00235716 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00235716 about?

NCT00235716 is a clinical study titled "A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease". 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.

What is the current status of trial NCT00235716?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 613 participants. The study started on 2007-08. Estimated completion is 2012-10.

What interventions are being tested in trial NCT00235716?

The interventions under investigation include: Placebo (DRUG), Memantine (DRUG), dl-alpha-tocopherol (DRUG).

Who is sponsoring clinical trial NCT00235716?

This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00235716's enrollment target sits among peer trials

613 598th of 2000 higher than 1,403 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00235716, the US trial registry maintained by the National Library of Medicine. NCT00235716 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.