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

August 29, 2007 updated by: Ludwig-Maximilians - University of Munich

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Active Comparator: 1
Drug: Galantamine (Reminyl®)
8mg - 24mg

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ludwig-Maximilians - University of Munich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2006

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DTI001
  • EudraCT 2005-003762-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer's Disease

Clinical Trials on Galantamine (Reminyl®)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings