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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Ludwig-Maximilians - University of Munich.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00523666
First received: August 29, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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 Intervention Phase
Alzheimer's Disease
Drug: Galantamine (Reminyl®)
Drug: Placebo/Galantamine (Reminyl®)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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®)

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Estimated Enrollment: 20
Study Start Date: September 2006
Estimated Study Completion Date: September 2008
Arms Assigned Interventions
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


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.

  Eligibility

Ages Eligible for Study:   55 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523666

Contacts
Contact: Stefan Teipel, MD +498951605860 stefan.teipel@med.uni-muenchen.de
Contact: Harald Hampel, MD harald.hampel@med.uni-muenchen.de

Locations
Germany
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
Investigators
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00523666     History of Changes
Other Study ID Numbers: DTI001, EudraCT 2005-003762-41
Study First Received: August 29, 2007
Last Updated: August 29, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:
Alzheimer's disease
diffusion tensor imaging

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Galantamine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 15, 2014