Effects of Memantine on Magnetic Resonance (MR) Spectroscopy in Subjects at Risk for Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Lidia Glodzik, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00933608
First received: July 2, 2009
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

Recent data show that marked cell damage precedes the clinical manifestation of Alzheimer's disease (AD). Hence, targeting populations at risk with pharmacological interventions is a possible strategy to lessen the burden of the disease. Cognitively normal individuals with subjective memory complaints (SMC) manifest biological characteristics consistent with early AD and are at risk for future cognitive decline. Family history of AD also constitutes a risk. In a previous study the investigators showed that memantine slows down the accumulation of phosphorylated tau in normal SMC subjects. Using a multivoxel high field MR spectroscopy (MRS) technique, the investigators also demonstrated that memantine decreased hippocampal glutamate. Both these findings may be consistent with the drug's anti-excitotoxic activity. In this new project the investigators propose to treat a sample of 12 presymptomatic individuals at risk (SMC and family history of AD) with memantine. This will be a double blind, placebo controlled study with a control group (12 non-treated subjects). The investigators will determine whether the effects of memantine as assessed by cognitive performance and MRS are present after 4 months of treatment and persist 2 months after discontinuation. MRS will be used to evaluate the effect of memantine on levels of the neurotransmitter glutamate and neuronal viability marker N-acetylaspartate (NAA) in the hippocampus. The investigators will test the following hypotheses:

  1. In subjects with SMC, memantine has modifying effects on brain biochemistry as reflected in MRS reductions in glutamate (reduced excitotoxicity) and increases in NAA (neuronal integrity).
  2. The effects of the drug persist (as a marker of sustained neuroprotection) and can be measured 2 months after discontinuation of the treatment.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Memantine on the Magnetic Resonance Spectroscopy (MRS) Measures of Neuronal Integrity in Subjects at Risk for Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • changes in N-acetylaspartate and glutamate [ Time Frame: 4 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: memantine Drug: memantine
participants will be asked to take memantine (20mg/day) for 16 weeks
Other Name: Namenda

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • presence of subjective memory complaints without objective evidence of impaired cognition
  • family history of Alzheimer's disease

Exclusion Criteria:

  • major depression
  • Parkinson's disease
  • stroke
  • seizures
  • uncontrolled diabetes or hypertension
  • current benzodiazepine use
  • substance abuse
  • contraindication for MRI
  • contraindications for memantine
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00933608

Locations
United States, New York
NYU School of Medicine, Dept. of Psychiatry, Center for Brain Health
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Forest Laboratories
Investigators
Principal Investigator: Lidia Glodzik, MD PhD NYU School of Medicine
  More Information

No publications provided

Responsible Party: Lidia Glodzik, Assistant Research Professor, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00933608     History of Changes
Other Study ID Numbers: NAM-MD-68
Study First Received: July 2, 2009
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
subjective memory complaints
cognitively healthy
family history
AD

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

ClinicalTrials.gov processed this record on August 19, 2014