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: Diagnostic, Open Label, Uncontrolled, Single Group Assignment

Study Primary Completion Date: June 2009

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: 1
  • New diagnosed patients with mild to moderate Alzheimer's Disease

Primary Measures

• Cerebral perfusion
  • Time Frame: baseline and after 12 weeks
    Safety Issue?: No

Secondary Measures

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

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

Lead Sponsor: University Hospital, Bonn

Overall Clinical Trial Officials and Contacts

Frank Jessen, MD Principal Investigator University Bonn  

Overall Contact: Frank Jessen, MD +49 (0) 228 28711109 frank.jessen@ukb.uni-bonn.de

Information obtained from ClinicalTrials.gov on September 05, 2008

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