Cognitive Rehabilitation in Alzheimer`s Disease

Alzheimer's Disease Clinical Trial

Official title:

Cognitive Rehabilitation in Alzheimer`s Disease (AD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02247180
• Other study ID #: A 2014-0113
• Status: Recruiting
• Phase: N/A
• First received: September 16, 2014
• Last updated: September 18, 2014
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2014
• Source: University of Rostock
• Contact: Elisabeth Kasper
• Phone: +49 0381 4949618
• Email: elisabeth.kasper[@]med.uni-rostock.de
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and ResearchGermany: Ethics CommissionGermany: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Behavioral:
• cognitive rehabilitation

• standardized cognitive training

Locations

Country	Name	City	State
Germany	Department of Psychosomatic Medicine, University of Rostock	Rostock

Sponsors (2)

Lead Sponsor	Collaborator
University of Rostock	German Center for Neurodegenerative Diseases (DZNE)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No