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NCT00097916 · ClinicalTrials.gov registry record · Phase 3

An Evaluation of the Safety and Efficacy of Memantine in Agitated Patients With Moderate to Severe Alzheimer's Disease

A Phase 3 study, sponsored by Forest Laboratories.

Completed
Registry status
Phase 3
Development phase
34
Enrollment target

NCT00097916: Completed Phase 3 study, sponsored by Forest Laboratories.

NCT00097916 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 34 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00097916, a Phase 3 study, has completed, sponsored by Forest Laboratories.

COMPLETED
Registry status
Phase 3
Development phase
34 participants
Enrollment target

Study Summary

About 65% of patients with severe Alzheimer's Disease (AD) will have symptoms of agitation. There are drawbacks associated with the currently available therapeutic interventions for agitation associated with Alzheimer's Disease. In a recent trial, in the group of patients with moderate to severe AD treated with memantine, there were fewer incidences of agitation. It is hypothesized that memantine will be effective in reducing the symptoms of agitation associated with moderate to severe Alzheimer's Disease.

Interventions

  • DRUG memantine HCl

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2004-09
Est. Completion 2006-04
Phase Phase 3
Forest Laboratories

145 total trials

What the finished NCT00097916 record still lists

NCT00097916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which memantine HCl is the first listed.

NCT00097916 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00097916 about?

NCT00097916 is a clinical study titled "An Evaluation of the Safety and Efficacy of Memantine in Agitated Patients With Moderate to Severe Alzheimer's Disease". About 65% of patients with severe Alzheimer's Disease (AD) will have symptoms of agitation. There are drawbacks associated with the currently available therapeutic interventions for agitation associated with Alzheimer's Disease. In a recent trial, in the group of patients with moderate to severe AD ...

What is the current status of trial NCT00097916?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 34 participants. The study started on 2004-09. Estimated completion is 2006-04.

What interventions are being tested in trial NCT00097916?

The interventions under investigation include: memantine HCl (DRUG).

Who is sponsoring clinical trial NCT00097916?

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 NCT00097916's enrollment target sits among peer trials

34 1905th of 2000 higher than 94 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 NCT00097916, the US trial registry maintained by the National Library of Medicine. NCT00097916 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.