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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University Hospital, Bonn.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Federal Ministry of Health, Germany
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00637442
First received: February 15, 2008
Last updated: November 8, 2010
Last verified: July 2010
  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

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

Resource links provided by NLM:


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) [ Time Frame: baseline, after 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Alzheimer's Disease Functional Assessment and Change Scale (ADFACS) [ Time Frame: baseline, after 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory (NPI) [ Time Frame: baseline, after 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Mini-Mental-Status-Examination (MMSE) [ Time Frame: baseline, after 12 and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2008
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CASL-MRI
Drug monitoring with CASL-MRI for new diagnosed patients with mild to moderate Alzheimer's Disease treated with Reminyl
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Department of Psychiatry, University Bonn
Bonn, Germany, 53127
Sponsors and Collaborators
University Hospital, Bonn
Federal Ministry of Health, Germany
Investigators
Principal Investigator: Frank Jessen, MD University Bonn
  More Information

No publications provided

Responsible Party: Frank Jessen, MD, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT00637442     History of Changes
Other Study ID Numbers: University Bonn
Study First Received: February 15, 2008
Last Updated: November 8, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Galantamine
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 20, 2014