Study of Memantine in Assessment of Selected Measures of Volumetric Magnetic Resonance Imaging (MRI) and Cognition in Moderate AD (Alzheimer's Disease)

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334906
• Other study ID #: MEM-MD-15
• Status: Completed
• Phase: Phase 4
• First received: June 6, 2006
• Last updated: January 3, 2008
• Start date: July 2005

Study information

• Verified date: January 2008
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• memantine HCl

Locations

Country	Name	City	State
United States	Forest Laboratories	Jersey City	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy
Primary	Total brain atrophy on MRI
Secondary	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
Secondary	Safety