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

Alzheimer's Disease Clinical Trial

— CASL-AD-01  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00637442
• Other study ID #: University Bonn
• Status: Active, not recruiting
• Phase: N/A
• First received: February 15, 2008
• Last updated: November 8, 2010
• Start date: February 2008

Study information

• Verified date: July 2010
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Reminyl retard
retard tablets once a day WEEK1-4: 8mg; WEEK 5-8: 16mg, WEEK 9-24: 24mg

Locations

Country	Name	City	State
Germany	Department of Psychiatry, University Bonn	Bonn

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bonn	Federal Ministry of Health, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral perfusion		baseline and after 12 weeks	No
Secondary	Change of Alzheimer Disease Assessment Scale, cognitive part (ADAScog)		baseline, after 12 and 24 weeks	No
Secondary	Alzheimer's Disease Functional Assessment and Change Scale (ADFACS)		baseline, after 12 and 24 weeks	No
Secondary	Neuropsychiatric Inventory (NPI)		baseline, after 12 and 24 weeks	No
Secondary	Mini-Mental-Status-Examination (MMSE)		baseline, after 12 and 24 weeks	No