search
Back to results

Cognitive Rehabilitation in Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
cognitive rehabilitation
standardized cognitive training
Sponsored by
University of Rostock
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychosomatic Medicine, University of RostockRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Rehabilitation

Cognitive Training

Arm Description

cognitive rehabilitation for 12 weeks

standardized cognitive training in the domesticity

Outcomes

Primary Outcome Measures

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)
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)
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)

Secondary Outcome Measures

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)
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)
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)

Full Information

First Posted
September 16, 2014
Last Updated
September 18, 2014
Sponsor
University of Rostock
Collaborators
German Center for Neurodegenerative Diseases (DZNE)
search

1. Study Identification

Unique Protocol Identification Number
NCT02247180
Brief Title
Cognitive Rehabilitation in Alzheimer's Disease
Official Title
Cognitive Rehabilitation in Alzheimer's Disease (AD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rostock
Collaborators
German Center for Neurodegenerative Diseases (DZNE)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Rehabilitation
Arm Type
Experimental
Arm Description
cognitive rehabilitation for 12 weeks
Arm Title
Cognitive Training
Arm Type
Active Comparator
Arm Description
standardized cognitive training in the domesticity
Intervention Type
Behavioral
Intervention Name(s)
cognitive rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
standardized cognitive training
Primary Outcome Measure Information:
Title
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)
Time Frame
prior intervention, after intervention (3 months), after 6 months
Title
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)
Time Frame
prior intervention, after intervention (3 months), after 6 months
Title
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)
Time Frame
prior intervention, after intervention (3 months), after 6 months
Secondary Outcome Measure Information:
Title
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)
Time Frame
prior intervention, after intervention (3 months), after 6 months
Title
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)
Time Frame
prior intervention, after intervention (3 months), after 6 months
Title
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)
Time Frame
prior intervention, after intervention (3 months), after 6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Kasper
Phone
+49 0381 4949618
Email
elisabeth.kasper@med.uni-rostock.de
First Name & Middle Initial & Last Name or Official Title & Degree
Yvonne Schmidt
Phone
+49 0381 4949471
Email
yvonne.schmidt@dzne.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Teipel, Prof.
Organizational Affiliation
Department of Psychosomatic Medicine, University of Rostock, Rostock, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychosomatic Medicine, University of Rostock
City
Rostock
ZIP/Postal Code
18147
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth Kasper
Phone
+49 381 4949618
Email
elisabeth.kasper@med.uni-rostock.de
First Name & Middle Initial & Last Name & Degree
Elisabeth Kasper

12. IPD Sharing Statement

Learn more about this trial

Cognitive Rehabilitation in Alzheimer's Disease

We'll reach out to this number within 24 hrs