Cognitive Rehabilitation in Alzheimer's Disease

Cognitive Rehabilitation in Alzheimer's Disease (AD)

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.

Study Overview

• Status: Unknown
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Behavioral: cognitive rehabilitation; Behavioral: standardized cognitive training

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: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabeth Kasper; Phone Number: +49 0381 4949618; Email: elisabeth.kasper@med.uni-rostock.de
• Study Contact Backup: Name: Yvonne Schmidt; Phone Number: +49 0381 4949471; Email: yvonne.schmidt@dzne.de

Study Locations

• Germany
  • Rostock, Germany, 18147
    • Recruiting
    • Department of Psychosomatic Medicine, University of Rostock
    • Contact: Elisabeth Kasper; Phone Number: +49 381 4949618; Email: elisabeth.kasper@med.uni-rostock.de
    • Principal Investigator: Elisabeth Kasper

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Rostock
• Collaborators: German Center for Neurodegenerative Diseases (DZNE)
• Investigators: Principal Investigator: Stefan Teipel, Prof., Department of Psychosomatic Medicine, University of Rostock, Rostock, Germany

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ANTICIPATED): May 1, 2015
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (ESTIMATE): September 23, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): September 23, 2014
• Last Update Submitted That Met QC Criteria: September 18, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: A 2014-0113