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Cognitive Rehabilitation in Alzheimer`s Disease

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ClinicalTrials.gov Identifier: NCT02247180
Recruitment Status : Unknown
Verified September 2014 by Elisabeth Kasper, University of Rostock.
Recruitment status was:  Recruiting
First Posted : September 23, 2014
Last Update Posted : September 23, 2014
Sponsor:
Collaborator:
German Center for Neurodegenerative Diseases (DZNE)
Information provided by (Responsible Party):
Elisabeth Kasper, University of Rostock

Tracking Information
First Submitted Date  ICMJE September 16, 2014
First Posted Date  ICMJE September 23, 2014
Last Update Posted Date September 23, 2014
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2014)
  • Change from baseline in activities of daily living measured by a test for action regulation and planning skills (HOTAP) to the end of intervention and to follow-up (6 months later) [ Time Frame: prior intervention, after intervention (3 months), after 6 months ]
  • Change from baseline in activities of daily living measured by an ADL-scale (Bayer-ADL) to the end of intervention and to follow-up (6 months later) [ Time Frame: prior intervention, after intervention (3 months), after 6 months ]
  • Change from baseline in behavioural memory abilities measured by a behavioural memory test (RBMT) to the end of intervention and to follow-up (6 months later) [ Time Frame: prior intervention, after intervention (3 months), after 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2014)
  • Change from baseline in general cognitive state measured by the Consortium to Establish a Registry for Alzheimer´s Disease (CERAD) to the end of intervention and to follow-up (6 months later) [ Time Frame: prior intervention, after intervention (3 months), after 6 months ]
  • Change from baseline in structural and functional connectivity of the brain measured by MRI to the end of intervention and to follow-up (6 months later) [ Time Frame: prior intervention, after intervention (3 months), after 6 months ]
  • Change from baseline in depression and quality of life measured by two scales (GDS, DEMQoL) to the end of intervention and to follow-up (6 months later) [ Time Frame: prior intervention, after intervention (3 months), after 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Rehabilitation in Alzheimer`s Disease
Official Title  ICMJE Cognitive Rehabilitation in Alzheimer`s Disease (AD)
Brief Summary This study aims to proof the efficacy of a cognitive rehabilitation program for patients with mild dementia in Alzheimers Disease with respect to activities of daily living.
Detailed Description This prospective randomized, single blind intervention study aims to proof a cognitive rehabilitation program for patients with mild dementia in Alzheimers Disease (AD). The investigators modified a manualized and established German behavioural therapy program (KORDIAL) to use in a group context. The respective modules contain multimodal and multiprofessional approaches to improve capabilities relevant to activities of daily living (external memory support, compensation strategies, training of everyday competence, communication training). The intervention group receives this therapy for 12 weeks. Age and gender matched participants with AD serve as active control sample receiving a standardized cognitive training in the domesticity. The primary outcome are measurements of skills in activities of daily living prior the intervention as well as at the end of the intervention (after 3 months) and after 6 months (Follow up).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Behavioral: cognitive rehabilitation
  • Behavioral: standardized cognitive training
Study Arms  ICMJE
  • Experimental: Cognitive Rehabilitation
    cognitive rehabilitation for 12 weeks
    Intervention: Behavioral: cognitive rehabilitation
  • Active Comparator: Cognitive Training
    standardized cognitive training in the domesticity
    Intervention: Behavioral: standardized cognitive 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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 18, 2014)
14
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • mild dementia in Alzheimer's disease (NINCDS-ADRDA)
  • Mini Mental State ≥ 17

Exclusion Criteria:

  • severe psychiatric disorder
  • severe brain disorder (epilepsy, tumor, stroke)
  • contraindication for MRI examination
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02247180
Other Study ID Numbers  ICMJE A 2014-0113
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elisabeth Kasper, University of Rostock
Study Sponsor  ICMJE University of Rostock
Collaborators  ICMJE German Center for Neurodegenerative Diseases (DZNE)
Investigators  ICMJE
Principal Investigator: Stefan Teipel, Prof. Department of Psychosomatic Medicine, University of Rostock, Rostock, Germany
PRS Account University of Rostock
Verification Date September 2014

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