Status:
COMPLETED
Memantine and Changes of Biological Markers and Brain PET Imaging in Alzheimer's Disease
Lead Sponsor:
Shanghai Mental Health Center
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-90 years
Phase:
PHASE4
Brief Summary
In AD, tau protein is abnormally hyperphosphorylated. Significant changes of hyperphosphorylated tau levels in CSF are found in AD patients. It has been shown in vitro that memantine can reverse abnor...
Detailed Description
1. To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on biological markers of subjects with Alzheimer's disease. 2. To investigate the effects of daily dosing of mema...
Eligibility Criteria
Inclusion
- Written informed consent
- Clinical diagnosis of Alzheimer's disease which meet the DSM-IV criteria.
- Subject has moderate to severe Alzheimer's disease as defined by a MMSE score 4 to 20 inclusive at screening.
- Hachinski Ischemia Score \< 4 at screening.
- Age ≥50 and ≤90 years.
- Availability of a responsible and steady caregiver to ensure treatment compliance and provide information for assessments.
Exclusion
- Severe renal impairment.
- History of seizures
- Systolic blood pressure \>160 or \< 90 mmHg or diastolic blood pressure \> 95 or \< 60 mmHg at the time of screening.
- Diagnosis of any concomitant life threatening illness.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00800709
Start Date
July 1 2008
End Date
October 1 2010
Last Update
December 3 2010
Active Locations (1)
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1
Department of Psychogeriatrics，Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030