Diffusion Tensor Weighted MRI in Alzheimer's Disease Modifying Treatment Effects of Galantamine (Reminyl®)
NCT ID: NCT00523666
Last Updated: 2007-08-31
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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UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2006-09-30
2008-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Galantamine (Reminyl®)
8mg - 24mg
2
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
Interventions
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Galantamine (Reminyl®)
8mg - 24mg
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
Eligibility Criteria
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Inclusion Criteria
* MMSE score \> 16
* no evidence for other psychiatric axis I disorders according to DSM- IV criteria
* no evidence for cerebrovascular disease (radiological confirmed), cardiac or cerebral infarct (three months before the study), thyroid disease and other neurodegenerative or neuroinflammatory disorders. No evidence for acute or unstable medical condition.
* no risk factors of hypertension, cardiac disease (e.g. angina pectoris, congestive heart failure, right bundle branch block, or arrhythmias), diabetes mellitus (stable within 3 months)
* no history of drug/alcohol abuse
* no history of panic attacks or claustrophobia (due to requirements of the MRI examinination)
* no surgical implants or non-fixed metallic particles
* patient has not taken a previously approved cholinesterase inhibitor or memantine, which has been discontinued at least 6 weeks prior to the Screening
* patient is able to provide written Informed Consent to participate study. If, at investigator's discretion, a patient is considered not to be capable to give legal consent, then written consent must also be obtained from the patient's legally acceptable representative.
Exclusion Criteria
* previous or current history of degenerative or ischemic disorders of the peripheral or central nervous system
* previous or current history of systemic disorders
* no ability to participate and no willing to give informed consent and comply with the study restrictions
* MMSE score \< 16 range
55 Years
95 Years
ALL
Yes
Sponsors
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Ludwig-Maximilians - University of Munich
OTHER
Principal Investigators
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Harald Hampel, MD
Role: STUDY_DIRECTOR
Dementia Research Section and Memory Clinic, Department of Psychiatry, Nussbaumstrasse 7, 80336 Munich, Germany
Stefan Teipel, MD
Role: PRINCIPAL_INVESTIGATOR
Dementia Research Section and Memory Clinic, Department of Psychiatry, Nussbaumstrasse 7, 80336 Munich, Germany
Locations
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Ludwig-Maximilian University of Munich
Munich, , Germany
Countries
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Central Contacts
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References
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Teipel SJ, Stahl R, Dietrich O, Schoenberg SO, Perneczky R, Bokde AL, Reiser MF, Moller HJ, Hampel H. Multivariate network analysis of fiber tract integrity in Alzheimer's disease. Neuroimage. 2007 Feb 1;34(3):985-95. doi: 10.1016/j.neuroimage.2006.07.047. Epub 2006 Dec 12.
Sydykova D, Stahl R, Dietrich O, Ewers M, Reiser MF, Schoenberg SO, Moller HJ, Hampel H, Teipel SJ. Fiber connections between the cerebral cortex and the corpus callosum in Alzheimer's disease: a diffusion tensor imaging and voxel-based morphometry study. Cereb Cortex. 2007 Oct;17(10):2276-82. doi: 10.1093/cercor/bhl136. Epub 2006 Dec 12.
Lim AWY, Schneider L, Loy C. Galantamine for dementia due to Alzheimer's disease and mild cognitive impairment. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD001747. doi: 10.1002/14651858.CD001747.pub4.
Blautzik J, Keeser D, Paolini M, Kirsch V, Berman A, Coates U, Reiser M, Teipel SJ, Meindl T. Functional connectivity increase in the default-mode network of patients with Alzheimer's disease after long-term treatment with Galantamine. Eur Neuropsychopharmacol. 2016 Mar;26(3):602-13. doi: 10.1016/j.euroneuro.2015.12.006. Epub 2015 Dec 10.
Other Identifiers
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EudraCT 2005-003762-41
Identifier Type: -
Identifier Source: secondary_id
DTI001
Identifier Type: -
Identifier Source: org_study_id