Alzheimer's DiseaseNCT02247180
Cognitive Rehabilitation in Alzheimer's Disease
A study testing cognitive rehabilitation and standardized cognitive training in people with Alzheimer's Disease, run by University of Rostock at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- cognitive rehabilitation and standardized cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- mild dementia in Alzheimer's disease (NINCDS-ADRDA)
- Mini Mental State ≥ 17
Who cannot join
- severe psychiatric disorder
- severe brain disorder (epilepsy, tumor, stroke)
- contraindication for MRI examination
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Psychosomatic Medicine, University of Rostock
Rostock, 18147
Elisabeth Kasper, +49 381 4949618, elisabeth.kasper@med.uni-rostock.de
Elisabeth Kasper
About this study
Official title: 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.
Read the 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).
- Conditions
- Alzheimer's Disease
- Being tested
- cognitive rehabilitation, standardized cognitive training
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive rehabilitationBehavioural
standardized cognitive trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Rehabilitation | Experimental | cognitive rehabilitation for 12 weeks Receives: Behavioral: cognitive rehabilitation |
| Cognitive Training | Active comparator | standardized cognitive training in the domesticity Receives: Behavioral: standardized cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: prior intervention, after intervention (3 months), after 6 months
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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)
Measured: prior intervention, after intervention (3 months), after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Neurodegenerative Diseases (DZNE)
- Responsible party
- Principal investigator, Elisabeth Kasper, University of Rostock
- Investigators
- Stefan Teipel, Prof., Principal investigator, Department of Psychosomatic Medicine, University of Rostock, Rostock, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247180
- Sponsor's protocol ID
- A 2014-0113
- Status last verified
- Sep 2014
- First submitted
- 16 Sep 2014
- Last updated
- 23 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation in Alzheimer's Disease (AD)
- ClinicalTrials.gov ID
- NCT02247180
- Acronym / sponsor ID
- A 2014-0113
- Conditions
- Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Collaborators
- German Center for Neurodegenerative Diseases (DZNE)
- Study start
- Sep 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 23 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Rehabilitation | Experimental | Behavioral: cognitive rehabilitationcognitive rehabilitation for 12 weeks |
| Cognitive Training | Active comparator | Behavioral: standardized cognitive trainingstandardized cognitive training in the domesticity |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- mild dementia in Alzheimer's disease (NINCDS-ADRDA)
- Mini Mental State ≥ 17
Key exclusion criteria (3 listed)
- severe psychiatric disorder
- severe brain disorder (epilepsy, tumor, stroke)
- contraindication for MRI examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive rehabilitation | Behavioural | Cognitive Rehabilitation |
| standardized cognitive training | Behavioural | Cognitive Training |
Primary outcome
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
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
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
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Teipel, Prof. principal investigator
Department of Psychosomatic Medicine, University of Rostock, Rostock, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive rehabilitation and standardized cognitive training in people with Alzheimer's Disease, run by University of Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth Kasper (+49 0381 4949618, elisabeth.kasper@med.uni-rostock.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2014.