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Sponsored by: |
New York University School of Medicine |
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Information provided by: | New York University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00933608 |
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:
Condition | Intervention | Phase |
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Alzheimer's Disease |
Drug: memantine |
Phase IV |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | Effects of Memantine on the Magnetic Resonance Spectroscopy (MRS) Measures of Neuronal Integrity in Subjects at Risk for Alzheimer's Disease |
Estimated Enrollment: | 24 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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memantine: Experimental |
Drug: memantine
participants will be asked to take memantine (20mg/day) for 16 weeks
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Ages Eligible for Study: | 55 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lidia Glodzik, MD PhD | 212-263-5698 | Lidia.Glodzik-Sobanska@nyumc.org |
United States, New York | |
NYU School of Medicine, Dept. of Psychiatry, Center for Brain Health | |
New York, New York, United States, 10016 |
Principal Investigator: | Lidia Glodzik, MD PhD | NYU School of Medicine |
Responsible Party: | NYUSM, Dept. of Psychiatry, Center for Brain Health ( Lidia Glodzik ) |
Study ID Numbers: | NAM-MD-68 |
Study First Received: | July 2, 2009 |
Last Updated: | July 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00933608 History of Changes |
Health Authority: | United States: Institutional Review Board |
subjective memory complaints cognitively healthy family history AD |
Excitatory Amino Acids Neurotransmitter Agents Alzheimer Disease Central Nervous System Diseases Healthy Brain Diseases Neurodegenerative Diseases Cognition Disorders |
Delirium, Dementia, Amnestic, Cognitive Disorders Dopamine Mental Disorders Memantine Dopamine Agents Dementia Delirium |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Alzheimer Disease Nervous System Diseases Antiparkinson Agents Central Nervous System Diseases Excitatory Amino Acid Agents Brain Diseases Neurodegenerative Diseases |
Pharmacologic Actions Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Therapeutic Uses Memantine Dopamine Agents Dementia Tauopathies Central Nervous System Agents Excitatory Amino Acid Antagonists |