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NCT00322153 · ClinicalTrials.gov registry record · Phase 3

A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease

A Phase 3 study, sponsored by Forest Laboratories.

Completed
Registry status
Phase 3
Development phase
677
Enrollment target

NCT00322153: Completed Phase 3 study, sponsored by Forest Laboratories.

NCT00322153 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 677 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00322153, a Phase 3 study, has completed, sponsored by Forest Laboratories.

COMPLETED
Registry status
Phase 3
Development phase
677 participants
Enrollment target

Study Summary

The objective of this study is to evaluate the safety, tolerability, and efficacy of memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of the Alzheimer's type on a concurrent acetylcholinesterase inhibitor (AChEI).

Primary Outcome

The SIB was developed for the evaluation of cognitive function in patients with more advanced dementia, and evaluates the areas of memory, language, praxis, orientation, and attention. The SIB test items consist of simple, one-step commands presented with gestural cues that are repeated if necessary. The test contains 51 items, and the range of possible scores is 0 to 100 (with 0 being the worst result). The SIB has been shown to be a valid and reliable instrument sensitive to longitudinal chang

Interventions

  • DRUG Placebo
  • DRUG memantine ER

Trial Details

FieldValue
Enrollment Target 677 participants
Start Date 2005-06
Est. Completion 2008-01
Phase Phase 3
Forest Laboratories

145 total trials

What the finished NCT00322153 record still lists

NCT00322153 is an interventional study that assigns participants to a tested intervention. The registered 677 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 (12% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00322153 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00322153 about?

NCT00322153 is a clinical study titled "A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease". The objective of this study is to evaluate the safety, tolerability, and efficacy of memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of the Alzheimer's type on a concurrent acetylcholinesterase inhibitor (AChEI).

What is the current status of trial NCT00322153?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 677 participants. The study started on 2005-06. Estimated completion is 2008-01.

What interventions are being tested in trial NCT00322153?

The interventions under investigation include: Placebo (DRUG), memantine ER (DRUG).

Who is sponsoring clinical trial NCT00322153?

This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00322153's enrollment target sits among peer trials

677 537th of 2000 higher than 1,464 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 NCT00322153, the US trial registry maintained by the National Library of Medicine. NCT00322153 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.