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

Primary Purpose

Alzheimer's Disease

Status

Unknown status

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Galantamine (Reminyl®)

Placebo/Galantamine (Reminyl®)

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, diffusion tensor imaging

Eligibility Criteria

55 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Ludwig-Maximilian University of MunichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00523666

First Posted

August 29, 2007

Last Updated

August 29, 2007

Sponsor

Ludwig-Maximilians - University of Munich

1. Study Identification

Unique Protocol Identification Number

NCT00523666

Brief Title

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

Official Title

Diffusion Tensor Weighted MRI in Alzheimer's Disease: Prediction and Mapping of Symptomatic and Disease Modifying Treatment Effects of Galantamine (Reminyl®)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2007

Overall Recruitment Status

Unknown status

Study Start Date

September 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Ludwig-Maximilians - University of Munich

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

Alzheimer's disease, diffusion tensor imaging

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Galantamine (Reminyl®)

Intervention Description

8mg - 24mg

Intervention Type

Drug

Intervention Name(s)

Placebo/Galantamine (Reminyl®)

Intervention Description

Patients are treated double-blind with placebo for 6 months, followed by treatment with Galantamine (Reminyl®) for another 6 months. Dose scheme: 8mg-24mg

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stefan Teipel, MD

Phone

+498951605860

stefan.teipel@med.uni-muenchen.de

First Name & Middle Initial & Last Name or Official Title & Degree

Harald Hampel, MD

harald.hampel@med.uni-muenchen.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harald Hampel, MD

Organizational Affiliation

Dementia Research Section and Memory Clinic, Department of Psychiatry, Nussbaumstrasse 7, 80336 Munich, Germany

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Stefan Teipel, MD

Organizational Affiliation

Dementia Research Section and Memory Clinic, Department of Psychiatry, Nussbaumstrasse 7, 80336 Munich, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ludwig-Maximilian University of Munich

City

Munich

ZIP/Postal Code

D-80336

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stefan Teipel, MD

First Name & Middle Initial & Last Name & Degree

Djyldyz Sydykova, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

17166745

Citation

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.

Results Reference

background

PubMed Identifier

17164468

Citation

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.

Results Reference

background

PubMed Identifier

26796681

Citation

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.

Results Reference

derived

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

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