Memantine and Changes of Biological Markers and Brain PET Imaging in Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT00800709|
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : December 3, 2010
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 abnormal hyperphosphorylation of tau in hippocampal neurons of rats. A statistically significant reduction of CSF phosphorylated tau at a preliminary 1-year follow-up was observed, from median 126 (interquartile range 107-153) to 108 (88-133) ng/l (p = 0.018). No statistically significant differences of total tau or Aβ42 were found (Gunnarsson MD, 2007).
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).
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: Memantine||Phase 4|
- To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on biological markers of subjects with Alzheimer's disease.
- 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.
- To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on cognitive function in subjects with Alzheimer's disease.
- 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.
- To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on short term memory.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Changes of Biological Markers and Brain PET Imaging and Clinical Effects of Memantine for Patients With Moderate to Severe Alzheimer's Disease: a 24 Week Double-blind, Randomized, Placebo-Controlled Study|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
U.S. FDA Resources
Initially memantine 5mg/day, titrated within the first month to a maintenance dose of 20mg/day
Other Name: Memantine hydrochloride
- biological markers of CSF [ Time Frame: 24 weeks ]
- 18[F]-FDG-PET of brain [ Time Frame: 24 weeks ]
- cognitive function [ Time Frame: 24 weeks ]
- behavior and activities of daily living [ Time Frame: 24 weeks ]
- short term memory [ Time Frame: 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800709
|Department of Psychogeriatrics，Shanghai Mental Health Center|
|Shanghai, Shanghai, China, 200030|
|Principal Investigator:||Shifu Xiao, MD. PhD.||Department of Psychogeriatrics，Shanghai Mental Health Center|