Overview

This trial is active, not recruiting.

Condition alzheimer's disease
Treatment reminyl retard
Sponsor University Hospital, Bonn
Collaborator Federal Ministry of Health, Germany
Start date February 2008
End date December 2010
Trial size 30 participants
Trial identifier NCT00637442, University Bonn

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Drug monitoring with CASL-MRI for new diagnosed patients with mild to moderate Alzheimer's Disease treated with Reminyl
reminyl retard
retard tablets once a day WEEK1-4: 8mg; WEEK 5-8: 16mg, WEEK 9-24: 24mg

Primary Outcomes

Measure
Cerebral perfusion
time frame: baseline and after 12 weeks

Secondary Outcomes

Measure
Change of Alzheimer Disease Assessment Scale, cognitive part (ADAScog)
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
Neuropsychiatric Inventory (NPI)
time frame: baseline, after 12 and 24 weeks
Mini-Mental-Status-Examination (MMSE)
time frame: baseline, after 12 and 24 weeks

Eligibility Criteria

Male or female participants from 50 years up to 80 years old.

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

Additional Information

Official title Continuous Arterial Spin Labeling (CASL) MRI for Monitoring and Prediction of Drug Therapy in Alzheimers Disease (AD)
Principal investigator Frank Jessen, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2010.
Information provided to ClinicalTrials.gov by University Hospital, Bonn.