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Clinical Trials/NCT02247180
NCT02247180
Unknown
N/A

Cognitive Rehabilitation in Alzheimer's Disease (AD)

University of Rostock1 site in 1 country14 target enrollmentSeptember 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alzheimer's Disease
Sponsor
University of Rostock
Enrollment
14
Locations
1
Primary Endpoint
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)
Last Updated
11 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
December 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Rostock
Responsible Party
Principal Investigator
Principal Investigator

Elisabeth Kasper

Dipl. psych

University of Rostock

Eligibility 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)(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)(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)(prior intervention, after intervention (3 months), after 6 months)

Study Sites (1)

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