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Status unknownNCT00637442CASL-AD-01Updated Nov 9, 2010

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

An interventional study of Reminyl retard in Alzheimer's Disease, sponsored by University Hospital, Bonn. Status unknown at 1 site in Germany. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-11-09.

Sponsored by University Hospital, Bonn · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2010), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
50 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • Alzheimer's Disease

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 30 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

University Hospital, Bonn is the lead sponsor of 154 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

Interventions

  • DrugReminyl retard

    retard tablets once a day WEEK1-4: 8mg; WEEK 5-8: 16mg, WEEK 9-24: 24mg

06

What researchers measure

Primary outcomes

  1. Cerebral perfusion

    Time frame: baseline and after 12 weeks

Secondary outcomes

  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

07

Study locations

1 site
  • Department of Psychiatry, University Bonn
    Bonn, 53127, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00637442
Lead sponsor
University Hospital, Bonn
Collaborators
Federal Ministry of Health, Germany
First posted
Mar 18, 2008
Start date
Feb 2008
Primary completion
Dec 2010 (estimated)
Last update
Nov 9, 2010

Study contacts

Frank Jessen, MD
principal investigator · University Bonn

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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