Dementia
Conditions
Keywords
Early dementia in Alzheimer's disease (MMSE ≥ 21)
Brief summary
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.
Interventions
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.
Patients and proxies who are assigned to treatment as usual
Sponsors
Study design
Eligibility
Inclusion criteria
* Mild dementia (MMSE \> 21) in Alzheimer's disease (ICD-10), proxy available
Exclusion criteria
* Acute of unstable psychiatric or physical disease, proxy unavailable * Participation in another trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional ability in the everyday context | Baseline, post treatment, 6 months post treatment |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life, depression, neuro-psychiatric symptoms | Same as for primary outcome |
Countries
Germany