Alzheimer's Disease
Conditions
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).
Interventions
BEHAVIORALcognitive rehabilitation
BEHAVIORALstandardized cognitive training
Sponsors
German Center for Neurodegenerative Diseases (DZNE)
University of Rostock
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| 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 |
Countries
Germany
Contacts
Primary ContactElisabeth Kasper
Backup ContactYvonne Schmidt
Outcome results
None listed