Continuous Arterial Spin Labeling (CASL) MRI for Monitoring and Prediction of Drug Therapy in Alzheimers Disease (AD) (CASL-AD-01)

November 8, 2010 updated by: University Hospital, Bonn
Examination of the correlation between the cerebral bloodflow and the clinical change under treatment with Reminyl retard® and the prediction of clinical change by measuring the cerebral bloodflow in patients with mild to moderate Alzheimer's Disease

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Germany
      • Bonn, Germany, 53127
        • Department of Psychiatry, University Bonn

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

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Possible Alzheimer's Disease according to ICD-10 and NINCDS-ADRDA
  • Underwritten study consent
  • No treatment with acetylcholinesterase inhibitors
  • Mini-Mental-State Examination: 12-25 points
  • Age: 50-80 Years
  • Orale contraception for women of child-bearing age

Exclusion Criteria:

  • Mental Disorders
  • Other Diseases of the CNS
  • Severe Illness
  • Contraindication for MRI-Scan
  • Contraindication for Galantamin (Reminyl retard®)
  • Participation at other clinical trials

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: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CASL-MRI
Drug monitoring with CASL-MRI for new diagnosed patients with mild to moderate Alzheimer's Disease treated with Reminyl
Drug: Reminyl retard
retard tablets once a day WEEK1-4: 8mg; WEEK 5-8: 16mg, WEEK 9-24: 24mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cerebral perfusion
Time Frame: baseline and after 12 weeks
baseline and after 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of Alzheimer Disease Assessment Scale, cognitive part (ADAScog)
Time Frame: baseline, after 12 and 24 weeks
baseline, after 12 and 24 weeks
Alzheimer's Disease Functional Assessment and Change Scale (ADFACS)
Time Frame: baseline, after 12 and 24 weeks
baseline, after 12 and 24 weeks
Neuropsychiatric Inventory (NPI)
Time Frame: baseline, after 12 and 24 weeks
baseline, after 12 and 24 weeks
Mini-Mental-Status-Examination (MMSE)
Time Frame: baseline, after 12 and 24 weeks
baseline, after 12 and 24 weeks

Collaborators and Investigators

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

Sponsor

University Hospital, Bonn

Collaborators

Federal Ministry of Health, Germany

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

February 1, 2008

Primary Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

February 15, 2008

First Submitted That Met QC Criteria

March 11, 2008

First Posted (Estimate)

March 18, 2008

Study Record Updates

Last Update Posted (Estimate)

November 9, 2010

Last Update Submitted That Met QC Criteria

November 8, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University Bonn

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 Reminyl retard

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe