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

NCT00322153 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 677

Last updated 2010-09-16

Study results available
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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).

Conditions

  • Dementia of the Alzheimer's Type

Interventions

DRUG

memantine ER

28mg(7mg capsules) once daily and oral administration for 24 weeks.

DRUG

Placebo

Matching placebo oral administration once daily.

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Stephen M Graham, PhD · Forest Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2007-10-31
Completion
2008-01-31

Countries

  • United States
  • Argentina
  • Chile
  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00322153 on ClinicalTrials.gov