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

NCT ID: NCT01329601

Last Updated: 2011-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-12-31

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.

Conditions

Dementia of the Alzheimer Type

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive Intervention

StaCog intervention to improve cognitive performance and activities of daily living in AD and MCI

Group Type: EXPERIMENTAL

StaCog, stage specific cognitive Intervention

Intervention Type: BEHAVIORAL

StaCog intervention to improve cognitive performance and activities of daily living in AD and MCI

Booklet-based training

Home based training of episodic memory using paper-pencil exercizes

Group Type: ACTIVE_COMPARATOR

booklet based training

Intervention Type: BEHAVIORAL

Home based training of episodic memory using paper-pencil exercizes

Interventions

StaCog, stage specific cognitive Intervention

StaCog intervention to improve cognitive performance and activities of daily living in AD and MCI

Intervention Type: BEHAVIORAL

booklet based training

Home based training of episodic memory using paper-pencil exercizes

Intervention Type: BEHAVIORAL

Other Intervention Names

Cognitive rehabilitation; Active behavioural control

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DZNE, German Center for Neurodegenerative Disorders, Germany

UNKNOWN

Sponsor Role: collaborator

University of Rostock

OTHER

Sponsor Role: lead

Responsible Party

Department of Psychiatry, University Rostock

Principal Investigators

Stefan J. Teipel, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Rostock

Locations

Department of Psychiatry, University of Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Stefan J. Teipel, Prof. Dr.

Role: CONTACT

stefan.teipel@med.uni-rostock.de

0049-381-494 ext. 9471

Facility Contacts

Stefan J. Teipel, Prof. Dr.

Role: primary

stefan.teipel@med.uni-rostock.de

0049-381-494 ext. 9471

Other Identifiers

Int_HRO_1

Identifier Type: -

Identifier Source: org_study_id