Continuous Arterial Spin Labeling (CASL) MRI for Monitori... | NCT00637442

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

NCT00637442

Sponsor

University Hospital, Bonn

Status

Unknown status

Last Update Posted

Nov 9, 2010Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Alzheimer's Disease

Interventions

Reminyl retard

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Dec 2010Estimated

Completion Date

Not provided

First Submitted Date

Feb 15, 2008

First Submission Date that Met QC Criteria

Mar 11, 2008

First Posted Date

Mar 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2010

Last Update Posted Date

Nov 9, 2010Estimated

Name	Class
Federal Ministry of Health, Germany	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Reminyl retard	Drug	retard tablets once a day WEEK1-4: 8mg; WEEK 5-8: 16mg, WEEK 9-24: 24mg	CASL-MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cerebral perfusion		baseline and after 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frank Jessen, MD	University of Bonn	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Psychiatry, University Bonn		Bonn		53127	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided