Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive Rehabilitation in Alzheimer`s Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Behavioral: cognitive rehabilitation Behavioral: standardized cognitive training Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Rehabilitation in Alzheimer`s Disease (AD)
Study Start Date : September 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: Cognitive Rehabilitation
cognitive rehabilitation for 12 weeks
Behavioral: cognitive rehabilitation
Active Comparator: Cognitive Training
standardized cognitive training in the domesticity
Behavioral: standardized cognitive training



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247180


Contacts
Layout table for location contacts
Contact: Elisabeth Kasper +49 0381 4949618 elisabeth.kasper@med.uni-rostock.de
Contact: Yvonne Schmidt +49 0381 4949471 yvonne.schmidt@dzne.de

Locations
Layout table for location information
Germany
Department of Psychosomatic Medicine, University of Rostock Recruiting
Rostock, Germany, 18147
Contact: Elisabeth Kasper    +49 381 4949618    elisabeth.kasper@med.uni-rostock.de   
Principal Investigator: Elisabeth Kasper         
Sponsors and Collaborators
University of Rostock
German Center for Neurodegenerative Diseases (DZNE)
Investigators
Layout table for investigator information
Principal Investigator: Stefan Teipel, Prof. Department of Psychosomatic Medicine, University of Rostock, Rostock, Germany

Layout table for additonal information
Responsible Party: Elisabeth Kasper, Dipl. psych, University of Rostock
ClinicalTrials.gov Identifier: NCT02247180     History of Changes
Other Study ID Numbers: A 2014-0113
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: September 23, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders