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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

April 1, 2011
April 5, 2011
January 2011
October 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01329601 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Effect of Cognitive Intervention in Alzheimer's Disease (AD) on Functional Cortical Networks in fMRI
Effect of the Stage Specific Cognitive Intervention Program on Functional Cortical Activation in Alzheimer's Disease

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Dementia of the Alzheimer Type
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
December 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact: Stefan J. Teipel, Prof. Dr. 0049-381-494 ext 9471 stefan.teipel@med.uni-rostock.de
Germany
 
NCT01329601
Int_HRO_1
No
Stefan Teipel, Department of Psychiatry, University Rostock
University of Rostock
DZNE, German Center for Neurodegenerative Disorders, Germany
Principal Investigator: Stefan J. Teipel, Prof. Dr. Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Rostock
University of Rostock
January 2011

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