Continuous Arterial Spin Labeling (CASL) MRI for Monitoring and Prediction of Drug Therapy in Alzheimers Disease (AD)
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...
Brief Summary
Official Title: “Continuous Arterial Spin Labeling (CASL) MRI for Monitoring and Prediction of Drug Therapy in Alzheimers Disease (AD)”
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 Type: Interventional
- Study Design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
- Study Primary Completion Date: December 2010
Intervention(s) in this Clinical Trial
- Drug: Reminyl retard
- retard tablets once a day WEEK1-4: 8mg; WEEK 5-8: 16mg, WEEK 9-24: 24mg
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: CASL-MRI
- Drug monitoring with CASL-MRI for new diagnosed patients with mild to moderate Alzheimer's Disease treated with Reminyl
Outcome Measures for this Clinical Trial
Primary Measures
- Cerebral perfusion
- Time Frame: baseline and after 12 weeks
Safety Issue?: No
- Time Frame: baseline and after 12 weeks
Secondary Measures
- Change of Alzheimer Disease Assessment Scale, cognitive part (ADAScog)
- Time Frame: baseline, after 12 and 24 weeks
Safety Issue?: No
- Time Frame: baseline, after 12 and 24 weeks
- Alzheimer's Disease Functional Assessment and Change Scale (ADFACS)
- Time Frame: baseline, after 12 and 24 weeks
Safety Issue?: No
- Time Frame: baseline, after 12 and 24 weeks
- Neuropsychiatric Inventory (NPI)
- Time Frame: baseline, after 12 and 24 weeks
Safety Issue?: No
- Time Frame: baseline, after 12 and 24 weeks
- Mini-Mental-Status-Examination (MMSE)
- Time Frame: baseline, after 12 and 24 weeks
Safety Issue?: No
- Time Frame: baseline, after 12 and 24 weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 50 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: University Hospital, Bonn Other
Overall Clinical Trial Officials and Contacts
Frank Jessen, MD Principal Investigator University Bonn
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00637442
Study ID Number: University Bonn
ClinicalTrials.gov Identifier: NCT00637442
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00637442
