Diffusion Tensor Weighted MRI in Alzheimer's Disease Modifying Treatment Effects of Galantamine (Reminyl®)
|ClinicalTrials.gov Identifier: NCT00523666|
Recruitment Status : Unknown
Verified August 2007 by Ludwig-Maximilians - University of Munich.
Recruitment status was: Recruiting
First Posted : August 31, 2007
Last Update Posted : August 31, 2007
Alzheimer's disease (AD) is characterized by progressive subcortical and cortical neuronal degeneration. AD patients differ in the time course of neuronal degeneration and accompanying cognitive decline.
With recent advances in MR imaging, including optimized data acquisition and processing techniques, tools that are especially well suited for tracking long-term pathological changes as well as drug treatment effects have become available. In addition to structural imaging, new acquisition and analysis techniques have been developed to determine integrity of subcortical fiber tracts in vivo.
In the present project we propose to determine predictors of disease progression and treatment response and investigate potential treatment effects on structural disease progression, covering the continuum from axonal degeneration to cortical neuronal loss taking advantage of recent advances in MRI acquisition and analysis techniques.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: Galantamine (Reminyl®) Drug: Placebo/Galantamine (Reminyl®)||Phase 4|
The outlined project will provide data to determine the value of cortical and subcortical volumetric and diffusion markers of neuronal degeneration to predict disease progression and response to (acetyl-)cholinergic treatment with Galantamine (Reminyl®). Furthermore, analysis of longitudinal MRI data in respect to cortical and subcortical atrophy and fiber degeneration will provide an estimate of the potential of new MRI analysis techniques to determine effects of (acetyl-)cholinergic treatment on rates of disease progression. Finally, the proposed study will allow determining the potential value of a new MRI technique, diffusion tensor imaging, to show the morphological correlate of cortical disconnection in AD and to map progression and treatment related effects on subcortical fiber tract integrity in AD.
The major scientific value of this project is the combined description of the effect of Galantamine (Reminyl®) on disease progression on the structural level of analysis in AD. The data from this project may help to identify predictors of treatment response and to elucidate the mechanisms of drug action of Galantamine (Reminyl®) in AD.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Diffusion Tensor Weighted MRI in Alzheimer's Disease: Prediction and Mapping of Symptomatic and Disease Modifying Treatment Effects of Galantamine (Reminyl®)|
|Study Start Date :||September 2006|
|Estimated Study Completion Date :||September 2008|
U.S. FDA Resources
|Active Comparator: 1||
Drug: Galantamine (Reminyl®)
8mg - 24mg
|Placebo Comparator: 2||
Drug: Placebo/Galantamine (Reminyl®)
Patients are treated double-blind with placebo for 6 months, followed by treatment with Galantamine (Reminyl®) for another 6 months.
Dose scheme: 8mg-24mg
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523666
|Contact: Stefan Teipel, MDfirstname.lastname@example.org|
|Contact: Harald Hampel, MDemail@example.com|
|Ludwig-Maximilian University of Munich||Recruiting|
|Munich, Germany, D-80336|
|Principal Investigator: Stefan Teipel, MD|
|Sub-Investigator: Djyldyz Sydykova, MD|
|Study Director:||Harald Hampel, MD||Dementia Research Section and Memory Clinic, Department of Psychiatry, Nussbaumstrasse 7, 80336 Munich, Germany|
|Principal Investigator:||Stefan Teipel, MD||Dementia Research Section and Memory Clinic, Department of Psychiatry, Nussbaumstrasse 7, 80336 Munich, Germany|