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
  Purpose

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.


Condition Intervention Phase
Dementia of the Alzheimer Type
Behavioral: StaCog, stage specific cognitive Intervention
Behavioral: booklet based training
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of the Stage Specific Cognitive Intervention Program on Functional Cortical Activation in Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by University of Rostock:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 24
Study Start Date: January 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Intervention
StaCog intervention to improve cognitive performance and activities of daily living in AD and MCI
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
Active Comparator: Booklet-based training
Home based training of episodic memory using paper-pencil exercizes
Behavioral: booklet based training
Home based training of episodic memory using paper-pencil exercizes
Other Name: Active behavioural control

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329601

Contacts
Contact: Stefan J. Teipel, Prof. Dr. 0049-381-494 ext 9471 stefan.teipel@med.uni-rostock.de

Locations
Germany
Department of Psychiatry, University of Rostock Recruiting
Rostock, Mecklenburg-Western Pomerania, Germany, 18147
Contact: Stefan J. Teipel, Prof. Dr.    0049-381-494 ext 9471    stefan.teipel@med.uni-rostock.de   
Principal Investigator: Stefan J. Teipel, Prof. Dr.         
Sponsors and Collaborators
University of Rostock
DZNE, German Center for Neurodegenerative Disorders, Germany
Investigators
Principal Investigator: Stefan J. Teipel, Prof. Dr. Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Rostock
  More Information

No publications provided

Responsible Party: Stefan Teipel, Department of Psychiatry, University Rostock
ClinicalTrials.gov Identifier: NCT01329601     History of Changes
Other Study ID Numbers: Int_HRO_1
Study First Received: April 1, 2011
Last Updated: April 5, 2011
Health Authority: Germany: Institutional Review Board of the Medical Faculty, University Rostock

Keywords provided by University of Rostock:
cognitive training
Alzheimer disease
tertiary prevention

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 21, 2014