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

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

This study is currently recruiting participants.

Verified by University Hospital, Bonn, January 2009

Sponsors and Collaborators:	University Hospital, Bonn German Federal Ministry of Health
Information provided by:	University Hospital, Bonn
ClinicalTrials.gov Identifier:	NCT00637442

Purpose

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	Intervention
Alzheimer's Disease	Drug: Reminyl retard

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Galantamine hydrobromide Galantamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Continuous Arterial Spin Labeling (CASL) MRI for Monitoring and Prediction of Drug Therapy in Alzheimers Disease (AD)

Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:

Cerebral perfusion [ Time Frame: baseline and after 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental New diagnosed patients with mild to moderate Alzheimer's Disease	Drug: Reminyl retard retard tablets once a day WEEK1-4: 8mg; WEEK 5-8: 16mg, WEEK 9-24: 24mg

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637442

Contacts

Contact: Frank Jessen, MD

+49 (0) 228 28711109

frank.jessen@ukb.uni-bonn.de

Locations

Germany
Department of Psychiatry, University Bonn	Recruiting
Bonn, Germany, 53127
Contact: Annika Spottke, MD +49 (0)228 287 16365 annika.spottke@ukb.uni-bonn.de
Sub-Investigator: Annika Spottke, MD

Sponsors and Collaborators

University Hospital, Bonn

German Federal Ministry of Health

Investigators

Principal Investigator:

Frank Jessen, MD

University Bonn

More Information

Responsible Party:	University Hospital, Bonn ( Frank Jessen, MD )
Study ID Numbers:	University Bonn
Study First Received:	February 15, 2008
Last Updated:	January 2, 2009
ClinicalTrials.gov Identifier:	NCT00637442
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Galantamine
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 16, 2009