Cognitive Rehabilitation in Alzheimer's Disease

Not Applicable

• Conditions: Alzheimer's Disease
• Interventions: Behavioral: cognitive rehabilitation; Behavioral: standardized cognitive training

• Registration Number: NCT02247180
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2014-09
• Study Start: 2014-09
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-18
• Last Update Submitted: 2014-09-18
• Study First Posted: 2014-09-23
• Last Update Posted: 2014-09-23
• Primary Completion: 2015-05
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Rehabilitation	cognitive rehabilitation	cognitive rehabilitation for 12 weeks
Cognitive Training	standardized cognitive training	standardized cognitive training in the domesticity

Primary Outcome Measures

Name	Time	Method
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)	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)	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)	prior intervention, after intervention (3 months), after 6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Psychosomatic Medicine, University of Rostock; 🇩🇪 Rostock, Germany