Cognitive Rehabilitation in Alzheimer's Disease

Study 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).

Official Title
-----------------
Cognitive Rehabilitation in Alzheimer's Disease (AD)

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Behavioral: cognitive rehabilitation
* Behavioral: standardized cognitive training


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Rehabilitation<br>cognitive rehabilitation for 12 weeks | Behavioral: cognitive rehabilitation<br> <br> |
| Active Comparator: Cognitive Training<br>standardized cognitive training in the domesticity | Behavioral: standardized cognitive training<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |