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

Sponsor
University Hospital, Bonn (Other)
Overall Status
Unknown status
CT.gov ID
NCT00637442
Collaborator
Federal Ministry of Health, Germany (Other)
30
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Reminyl retard
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Continuous Arterial Spin Labeling (CASL) MRI for Monitoring and Prediction of Drug Therapy in Alzheimers Disease (AD)
Study Start Date :
Feb 1, 2008
Anticipated Primary Completion Date :
Dec 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Cerebral perfusion [baseline and after 12 weeks]

Secondary Outcome Measures

  1. Change of Alzheimer Disease Assessment Scale, cognitive part (ADAScog) [baseline, after 12 and 24 weeks]

  2. Alzheimer's Disease Functional Assessment and Change Scale (ADFACS) [baseline, after 12 and 24 weeks]

  3. Neuropsychiatric Inventory (NPI) [baseline, after 12 and 24 weeks]

  4. Mini-Mental-Status-Examination (MMSE) [baseline, after 12 and 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Psychiatry, University Bonn Bonn Germany 53127

Sponsors and Collaborators

  • University Hospital, Bonn
  • Federal Ministry of Health, Germany

Investigators

  • Principal Investigator: Frank Jessen, MD, University Bonn

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00637442
Other Study ID Numbers:
  • University Bonn
First Posted:
Mar 18, 2008
Last Update Posted:
Nov 9, 2010
Last Verified:
Jul 1, 2010
Additional relevant MeSH terms:
Alzheimer Disease
Galantamine

Study Results

No Results Posted as of Nov 9, 2010