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

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ClinicalTrials.gov Identifier: NCT00637442
Recruitment Status : Unknown
Verified July 2010 by University Hospital, Bonn.
Recruitment status was:  Active, not recruiting
First Posted : March 18, 2008
Last Update Posted : November 9, 2010
Sponsor:
Collaborator:
Federal Ministry of Health, Germany
Information provided by:
University Hospital, Bonn

Brief 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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Reminyl retard Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Continuous Arterial Spin Labeling (CASL) MRI for Monitoring and Prediction of Drug Therapy in Alzheimers Disease (AD)
Study Start Date : February 2008
Estimated Primary Completion Date : December 2010


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Cerebral perfusion [ Time Frame: baseline and after 12 weeks ]

Secondary Outcome Measures :
  1. Change of Alzheimer Disease Assessment Scale, cognitive part (ADAScog) [ Time Frame: baseline, after 12 and 24 weeks ]
  2. Alzheimer's Disease Functional Assessment and Change Scale (ADFACS) [ Time Frame: baseline, after 12 and 24 weeks ]
  3. Neuropsychiatric Inventory (NPI) [ Time Frame: baseline, after 12 and 24 weeks ]
  4. Mini-Mental-Status-Examination (MMSE) [ Time Frame: baseline, after 12 and 24 weeks ]


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Frank Jessen, MD, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT00637442     History of Changes
Other Study ID Numbers: University Bonn
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: July 2010

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