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

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Forest Laboratories

Status and phase

Completed
Phase 3

Conditions

Alzheimer's Disease

Treatments

Drug: memantine HCl

Study type

Interventional

Funder types

Industry

Identifiers

NCT00097916
MEM-MD-23

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

50+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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