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

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00334906
First received: June 6, 2006
Last updated: January 3, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: memantine HCl
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Efficacy
  • Total brain atrophy on MRI

Secondary Outcome Measures:
  • 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
  • Safety

Estimated Enrollment: 75
Study Start Date: July 2005
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334906

Locations
United States, New Jersey
Forest Laboratories
Jersey City, New Jersey, United States, 07311
Sponsors and Collaborators
Forest Laboratories
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00334906     History of Changes
Other Study ID Numbers: MEM-MD-15
Study First Received: June 6, 2006
Last Updated: January 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
memantine
Alzheimer's disease
MRI
moderate Alzheimer's disease

Additional relevant MeSH terms:
Brain Diseases
Alzheimer Disease
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Memantine
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014