NCT00637442

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 18, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

November 9, 2010

Status Verified

July 1, 2010

Enrollment Period

2.8 years

First QC Date

February 15, 2008

Last Update Submit

November 8, 2010

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Cerebral perfusion

    baseline and after 12 weeks

Secondary Outcomes (4)

  • Change of Alzheimer Disease Assessment Scale, cognitive part (ADAScog)

    baseline, after 12 and 24 weeks

  • Alzheimer's Disease Functional Assessment and Change Scale (ADFACS)

    baseline, after 12 and 24 weeks

  • Neuropsychiatric Inventory (NPI)

    baseline, after 12 and 24 weeks

  • Mini-Mental-Status-Examination (MMSE)

    baseline, after 12 and 24 weeks

Study Arms (1)

CASL-MRI

EXPERIMENTAL

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

Drug: Reminyl retard

Interventions

Reminyl retardDRUG

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

CASL-MRI

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Mental Disorders
  • Other Diseases of the CNS
  • Severe Illness
  • Contraindication for MRI-Scan
  • Contraindication for Galantamin (Reminyl retard®)
  • Participation at other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, University Bonn

Bonn, 53127, Germany

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Frank Jessen, MD

    University Bonn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2008

First Posted

March 18, 2008

Study Start

February 1, 2008

Primary Completion

December 1, 2010

Last Updated

November 9, 2010

Record last verified: 2010-07

Locations

DE(1)