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

Primary Purpose

Alzheimer's Disease

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Reminyl retard
Sponsored by
University Hospital, Bonn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry, University Bonn

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CASL-MRI

Arm Description

Drug monitoring with CASL-MRI for new diagnosed patients with mild to moderate Alzheimer's Disease treated with Reminyl

Outcomes

Primary Outcome Measures

Cerebral perfusion

Secondary Outcome Measures

Change of Alzheimer Disease Assessment Scale, cognitive part (ADAScog)
Alzheimer's Disease Functional Assessment and Change Scale (ADFACS)
Neuropsychiatric Inventory (NPI)
Mini-Mental-Status-Examination (MMSE)

Full Information

First Posted
February 15, 2008
Last Updated
November 8, 2010
Sponsor
University Hospital, Bonn
Collaborators
Federal Ministry of Health, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00637442
Brief Title
Continuous Arterial Spin Labeling (CASL) MRI for Monitoring and Prediction of Drug Therapy in Alzheimers Disease (AD)
Acronym
CASL-AD-01
Official Title
Continuous Arterial Spin Labeling (CASL) MRI for Monitoring and Prediction of Drug Therapy in Alzheimers Disease (AD)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Bonn
Collaborators
Federal Ministry of Health, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CASL-MRI
Arm Type
Experimental
Arm Description
Drug monitoring with CASL-MRI for new diagnosed patients with mild to moderate Alzheimer's Disease treated with Reminyl
Intervention Type
Drug
Intervention Name(s)
Reminyl retard
Intervention Description
retard tablets once a day WEEK1-4: 8mg; WEEK 5-8: 16mg, WEEK 9-24: 24mg
Primary Outcome Measure Information:
Title
Cerebral perfusion
Time Frame
baseline and after 12 weeks
Secondary Outcome Measure Information:
Title
Change of Alzheimer Disease Assessment Scale, cognitive part (ADAScog)
Time Frame
baseline, after 12 and 24 weeks
Title
Alzheimer's Disease Functional Assessment and Change Scale (ADFACS)
Time Frame
baseline, after 12 and 24 weeks
Title
Neuropsychiatric Inventory (NPI)
Time Frame
baseline, after 12 and 24 weeks
Title
Mini-Mental-Status-Examination (MMSE)
Time Frame
baseline, after 12 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Jessen, MD
Organizational Affiliation
University Bonn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, University Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany

12. IPD Sharing Statement

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

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