DementiaKORDIALNCT00735046
Cognitive Behavioural Therapy of Early Dementia
An observational study of Dementia, run by Technical University of Munich at 1 site in Germany.
Trial summary
A randomized, controlled, parallel-group trial to evaluate the efficacy of a cognitive behavioral therapy for patients with early dementia. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Dementia
- What is being tested?
- Cognitive behavioral therapy for early Alzheimer's disease
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2008to Apr 2010
- Phase
- Observational
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to memory clinics and specialist (psychiatrist, neurologist) offices
Who may be able to join
- Mild dementia (MMSE > 21) in Alzheimer's disease (ICD-10), proxy available
Who cannot join
- Acute of unstable psychiatric or physical disease, proxy unavailable
- Participation in another trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
Prof. Dr. A. Kurz, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technische Universitaet Muenchen
Munich, Bavaria, 81675
About this study
Official title: Cognitive Behavioural Resource-based Therapy of Early Dementia in the Everyday Setting
A randomized, controlled, parallel-group trial to evaluate the efficacy of a cognitive behavioral therapy for patients with early dementia.
Read the detailed description
The KORDIAL study is a randomized, controlled, parallel-group trial evaluating the efficacy of a cognitive behavioral therapy for patients at the early stage of Alzheimer's disease. The 3-month experimental intervention consists of 12 individual sessions with regular involvement of carers or other patient proxies. Strategies for improving the patient's coping ability and for enhancing their psychological well-being are combined. The primary outcome criterion is functioning in the everyday context after completion of the intervention and after another 6 months. The control condition will be treatment as usual. The study will be conducted in 5 university outpatient units and in 5 specialist offices.
- Conditions
- Dementia
- Being tested
- Cognitive behavioral therapy for early Alzheimer's disease, Control
- Keywords
- Early dementia in Alzheimer's disease (MMSE ≥ 21)
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy for early Alzheimer's diseaseBehavioural
12 weekly individual sessions, total duration 3 months, regular involvement of patient's proxy ever second session. Intervention is manualized but is flexible with regard to individual resources and needs.
ControlOther
Patients and proxies who are assigned to treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| 1 | Intervention Receives: Behavioral: Cognitive behavioral therapy for early Alzheimer's disease | |
| 2 | control Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional ability in the everyday context
Measured: Baseline, post treatment, 6 months post treatment
Secondary outcomes (1)
Quality of life, depression, neuro-psychiatric symptoms
Measured: Same as for primary outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startApr 2008
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leipzig, Zentralinstitut für Seelische Gesundheit Mannheim, Humboldt-Universität zu Berlin
- Investigators
- Alexander Kurz, MD, Study director, Klinikum rechts der Isar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735046
- Sponsor's protocol ID
- KOR-683-KUR-0000-I
- Acronym
- KORDIAL
- Status last verified
- Jul 2008
- First submitted
- 13 Aug 2008
- Last updated
- 14 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kliegel M, Eschen A, Thone-Otto AI. Planning and realization of complex intentions in traumatic brain injury and normal aging. Brain Cogn. 2004 Oct;56(1):43-54. doi: 10.1016/j.bandc.2004.05.005.
PubMed 15380875Werheid K, Thone-Otto AI. [Cognitive training in Alzheimer's dementia]. Nervenarzt. 2006 May;77(5):549-57. doi: 10.1007/s00115-005-1998-2. German.
PubMed 16228161Kurz A, Pohl C, Ramsenthaler M, Sorg C. Cognitive rehabilitation in patients with mild cognitive impairment. Int J Geriatr Psychiatry. 2009 Feb;24(2):163-8. doi: 10.1002/gps.2086.
PubMed 18636436
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Resource-based Therapy of Early Dementia in the Everyday Setting
- ClinicalTrials.gov ID
- NCT00735046
- Acronym / sponsor ID
- KORDIAL / KOR-683-KUR-0000-I
- Conditions
- Dementia
- Keywords
- Early dementia in Alzheimer's disease (MMSE ≥ 21)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- University of Leipzig, Zentralinstitut für Seelische Gesundheit Mannheim, Humboldt-Universität zu Berlin
- Study start
- Apr 2008
- Study completion
- Apr 2010 (actual)
- First posted
- 14 Aug 2008 (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.
A randomized, controlled, parallel-group trial to evaluate the efficacy of a cognitive behavioral therapy for patients with early dementia.
Detailed description
The KORDIAL study is a randomized, controlled, parallel-group trial evaluating the efficacy of a cognitive behavioral therapy for patients at the early stage of Alzheimer's disease. The 3-month experimental intervention consists of 12 individual sessions with regular involvement of carers or other patient proxies. Strategies for improving the patient's coping ability and for enhancing their psychological well-being are combined. The primary outcome criterion is functioning in the everyday context after completion of the intervention and after another 6 months. The control condition will be treatment as usual. The study will be conducted in 5 university outpatient units and in 5 specialist offices.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Cognitive behavioral therapy for early Alzheimer's diseaseIntervention |
| 2 | – | Other: Controlcontrol |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to memory clinics and specialist (psychiatrist, neurologist) offices
Key inclusion criteria (1 listed)
- Mild dementia (MMSE > 21) in Alzheimer's disease (ICD-10), proxy available
Key exclusion criteria (2 listed)
- Acute of unstable psychiatric or physical disease, proxy unavailable
- Participation in another trial
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 behavioral therapy for early Alzheimer's disease12 weekly individual sessions, total duration 3 months, regular involvement of patient's proxy ever second session. Intervention is manualized but is flexible with regard to individual resources and needs. | Behavioural | 1 |
| ControlPatients and proxies who are assigned to treatment as usual | Other | 2 |
Primary outcome
Functional ability in the everyday context
Time frame: Baseline, post treatment, 6 months post treatment
1 secondary outcome
Quality of life, depression, neuro-psychiatric symptoms
Time frame: Same as for primary outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2011.
- Background: PubMed 15380875Kliegel M, Eschen A, Thone-Otto AI. Planning and realization of complex intentions in traumatic brain injury and normal aging. Brain Cogn. 2004 Oct;56(1):43-54. doi: 10.1016/j.bandc.2004.05.005.
- Background: PubMed 16228161Werheid K, Thone-Otto AI. [Cognitive training in Alzheimer's dementia]. Nervenarzt. 2006 May;77(5):549-57. doi: 10.1007/s00115-005-1998-2. German.
- Background: PubMed 18636436Kurz A, Pohl C, Ramsenthaler M, Sorg C. Cognitive rehabilitation in patients with mild cognitive impairment. Int J Geriatr Psychiatry. 2009 Feb;24(2):163-8. doi: 10.1002/gps.2086.
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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.
Alexander Kurz, MD study director
Klinikum rechts der Isar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Technical University of Munich 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 14 Jan 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional ability in the everyday context (time frame: Baseline, post treatment, 6 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00735046, which also lists 3 linked publications.
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 14 Jan 2011.