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

A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Non-Institutionalized Agitated Patients With Moderate to Severe Alzheimer's Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00097916

Enrollment

Registered

2004-12-02

Start date

2004-09-30

Completion date

2006-04-30

Last updated

2012-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

memantine HCl, Dementia, Agitation, Alzheimer Disease

Brief 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

DRUGmemantine HCl

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* Moderate to Severe Alzheimer's Disease with a score greater than or equal to 4 on agitation/aggression domain of NPI * Stable dose of donepezil for 3 months

Exclusion criteria

* Other evidence of psychiatric disorders * Oncologic diagnosis * Clinically significant gastrointestinal, renal, hepatic, endocrine or cardiovascular disease

Design outcomes

Primary

Measure	Time frame
Neuropsychiatric Inventory	—

Secondary

Measure	Time frame
Cohen Mansfield Agitation Inventory	—
Clinical Global Impression Scale	—
ADCS-ADL	—
Agitation/aggression domain of Neuropsychiatric Inventory (NPI)	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026