Memantine and Changes of Biological Markers and Brain PET Imaging in Alzheimer's Disease
NCT ID: NCT00800709
Last Updated: 2010-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
26 participants
INTERVENTIONAL
2008-07-31
2010-10-31
Brief Summary
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FDG-PET has the unique ability to estimate the local cerebral metabolic rate of glucose consumption, thus providing information on the distribution of neuronal death and synapse dysfunction in AD in vivo (Herholz K. 2003). Synaptic dysfunction and loss induce a reduction in neuronal energy demand that results in decreased glucose metabolism. Hypometabolism in AD is thought to reflect loss of synaptic activity and density (Herholz K. 2003; Mielke R, et al. 1998).
Another biological markers such as inflammatory factor and APOEε4 also play a part in the onset of AD (Glodzik-Sobanska L, 2007).
Detailed Description
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2. To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on 18\[F\]-FDG-PET of brain in subjects with Alzheimer's disease.
3. To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on cognitive function in subjects with Alzheimer's disease.
4. To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on measures of behavior and activities of daily living of subjects with Alzheimer's disease.
5. To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on short term memory.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Memantine
Memantine
Initially memantine 5mg/day, titrated within the first month to a maintenance dose of 20mg/day
Interventions
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Memantine
Initially memantine 5mg/day, titrated within the first month to a maintenance dose of 20mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of Alzheimer's disease which meet the DSM-IV criteria.
3. Subject has moderate to severe Alzheimer's disease as defined by a MMSE score 4 to 20 inclusive at screening.
4. Hachinski Ischemia Score \< 4 at screening.
5. Age ≥50 and ≤90 years.
6. Availability of a responsible and steady caregiver to ensure treatment compliance and provide information for assessments.
Exclusion Criteria
2. History of seizures
3. Systolic blood pressure \>160 or \< 90 mmHg or diastolic blood pressure \> 95 or \< 60 mmHg at the time of screening.
4. Diagnosis of any concomitant life threatening illness.
50 Years
90 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Shanghai Mental Health Center
OTHER
Responsible Party
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Shanghai Mental Heath Center
Principal Investigators
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Shifu Xiao, MD. PhD.
Role: PRINCIPAL_INVESTIGATOR
Department of Psychogeriatrics，Shanghai Mental Health Center
Locations
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Department of Psychogeriatrics，Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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IIT_12484A
Identifier Type: -
Identifier Source: org_study_id