Effect of Cognitive Intervention in Alzheimer's Disease (AD) on Functional Cortical Networks in fMRI (ECIF)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2011 by University of Rostock.
Recruitment status was Recruiting

Sponsor:

Collaborator:

DZNE, German Center for Neurodegenerative Disorders, Germany

Information provided by:

University of Rostock

ClinicalTrials.gov Identifier:

NCT01329601

First received: April 1, 2011

Last updated: April 5, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 1, 2011

Last Updated Date

April 5, 2011

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

California Verbal Learning Test [ Time Frame: Detecting changes between two different time points (baseline and 6 months) ] [ Designated as safety issue: No ]

Cognitive test for episodic memory

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01329601 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

functional cortical activity in fMRI [ Time Frame: Detecting changes between two different time points (baseline and 6 months) ] [ Designated as safety issue: No ]

Measure of cortical activation during n-back letter recognition with emotional modulation

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Cognitive Intervention in Alzheimer's Disease (AD) on Functional Cortical Networks in fMRI

Official Title ^ICMJE

Effect of the Stage Specific Cognitive Intervention Program on Functional Cortical Activation in Alzheimer's Disease

Brief Summary

The study aims to detect the effect of a structured cognitive rehabilitation program, teh stage specific intervention STACog, on cognitive performance and functional activation in fMRI in a group of patients with mild cognitive impairment and dementia due to Alzheimer's disease compared to a waiting group control sample. Baseline performance in cognitive tests and fMRI will further be assessed compared to healthy control subjects.

Detailed Description

Subject of the proposed project is to offer based on existing theoretical principles and methods stage-related, reproducible, relevant to everyday life group training in German for people with aMCI and slightly severe AD and compared with a - in terms of goal variables - to be less effective prestigious intervention . It is believed that the "active treatment" - in the intervention group, the overall level of functioning can longer be maintained and that positive transfer effects on non-cognitive level - to achieve and cognitive level - here at nationals. In addition, information is expected that the conversion rate of people with dementia and aMCI cut to a further loss of independence in humans can be delayed slightly with severe AD. The project aims to provide data to estimate the effect sizes of intervention can be determined on the basis of group size and duration of ongoing investigations.

Involving functional imaging measures, the intervention study, an adequate platform for the detection of intervention effects on neurobiological basis using fMRI dar. Here, the cerebral blood flow in specific activation as a measure of neuronal and synaptic activity and integrity both in cross-section of a subsample of healthy elderly people studied determined and changes in cerebral activity patterns in people with severe AD, aMCI or slightly in comparison pre-/post interventions. There are detectable much earlier in the pathogenesis of functional changes as structural, using fMRI, the study is to make a significant contribution to prove whether a modular cognitive intervention altered neural and synaptic activity and whether this change is accompanied by an improvement in cognitive performance.

A complete and proven effectiveness of cognitive group training could make a significant contribution that people with MCI and severe AD easily submit their own initiative mental condition, and add itself to sustain the intellectual, emotional and social potential. As a long-term perspective, the results for the optimization of cognitive intervention programs and continue to implement the organizations of the open and contribute stationary the elderly and specialized medical facilities and other medical facilities.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Dementia of the Alzheimer Type

Intervention ^ICMJE

Behavioral: StaCog, stage specific cognitive Intervention
StaCog intervention to improve cognitive performance and activities of daily living in AD and MCI

Other Name: Cognitive rehabilitation
Behavioral: booklet based training
Home based training of episodic memory using paper-pencil exercizes

Other Name: Active behavioural control

Study Arm (s)

Experimental: Cognitive Intervention
StaCog intervention to improve cognitive performance and activities of daily living in AD and MCI

Intervention: Behavioral: StaCog, stage specific cognitive Intervention
Active Comparator: Booklet-based training
Home based training of episodic memory using paper-pencil exercizes

Intervention: Behavioral: booklet based training

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2011

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

diagnosis of Mild Cognitive Impairment, Amnestic type (single domain) according to Petersen criteria or a low grade AD according to ICD-10/NINCDS-ADRDA

Exclusion Criteria:

Major depression
severe visual and acoustic impairment
severe physical impairments
known malignancy
laboratory elevated inflammatory markers (ESR, CRP, leukocytes)
stroke
brain trauma
epilepsy
previous participation in a memory training
patients receiving drug treatment (antidepressants, neuroleptics, anti-dementia, other brain performance enhancing drugs) at least three months prior to study initiation for the duration of the project are at a stable dosage

Gender

Both

Ages

55 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Stefan J. Teipel, Prof. Dr.

0049-381-494 ext 9471

stefan.teipel@med.uni-rostock.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01329601

Other Study ID Numbers ^ICMJE

Int_HRO_1

Has Data Monitoring Committee

Responsible Party

Stefan Teipel, Department of Psychiatry, University Rostock

Study Sponsor ^ICMJE

University of Rostock

Collaborators ^ICMJE

DZNE, German Center for Neurodegenerative Disorders, Germany

Investigators ^ICMJE

Principal Investigator:

Stefan J. Teipel, Prof. Dr.

Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Rostock

Information Provided By

University of Rostock

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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