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Clinical Trials/NCT00334906
NCT00334906CompletedPhase 4

An Open-Label Exploratory Study With Memantine: Assessment of Selected Measures of Volumetric MRI and Cognition in Patients With Moderate Dementia of the Alzheimer's Type

Forest Laboratories2 sites in 1 country75 target enrollmentStarted: July 1, 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
75
Locations
2
Primary Endpoint
Total brain atrophy on MRI
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to characterize the progression of disease using volumetric MRI techniques and cognitive outcome measures in patients with moderate dementia of the Alzheimer's type treated with open-label memantine.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Ambulatory male or female patients at least 50 years of age (females at least 2 years postmenopausal)
  • •A diagnosis of probable AD [according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Associations (NINCDS-ADRDA) criteria] of moderate severity [Mini-Mental State Examination score between 15 and 20, inclusive]
  • •On a stable dose of Food and Drug Administration (FDA)-approved acetylcholinesterase inhibitor

Exclusion Criteria

  • •Current Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) Axis I disorder other than AD
  • •Previous imaging results not consistent with the diagnosis of AD
  • •Modified Hachinski Ischemia Score greater than 4
  • •Evidence of other neurologic disorders
  • •Inability to participate in MRI testing
  • •No clinically significant systemic disease
  • •A known or suspected history of alcohol or drug abuse in the past 10 years
  • •Taking excluded medication
  • •Previous treatment with commercial memantine

Outcomes

Primary Outcomes

Total brain atrophy on MRI

Efficacy

Secondary Outcomes

  • Safety
  • Other measures of brain atrophy on MRI, change from baseline in selected cognitive measures assessing multiple cognitive domains including memory, attention, motor-speed, auditory comprehension, and verbal fluency

Investigators

Sponsor
Forest Laboratories
Sponsor Class
Industry

Study Sites (2)

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