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Diffusion Tensor Weighted MRI in Alzheimer's Disease Modifying Treatment Effects of Galantamine (Reminyl®)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Ludwig-Maximilians - University of Munich

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • male of female patients aged ≥ 55years, fulfilling criteria of the National Institute of Neurological and Communicative Disease and Stroke (NINCDS) and the Alzheimer's Disease and Related Disorders Association (ADRDA) for the diagnosis of clinically probable AD
  • 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:

  • no evidence of memory or other cognitive impairments, verified by clinical history and cognitive testing
  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00523666

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Contact: Stefan Teipel, MD +498951605860
Contact: Harald Hampel, MD

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Ludwig-Maximilian University of Munich Recruiting
Munich, Germany, D-80336
Principal Investigator: Stefan Teipel, MD         
Sub-Investigator: Djyldyz Sydykova, MD         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
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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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00523666     History of Changes
Other Study ID Numbers: DTI001
EudraCT 2005-003762-41
First Posted: August 31, 2007    Key Record Dates
Last Update Posted: August 31, 2007
Last Verified: August 2007
Keywords provided by Ludwig-Maximilians - University of Munich:
Alzheimer's disease
diffusion tensor imaging
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents