Alzheimer Disease, Dementia, Mild Cognitive Impairment
Conditions
Keywords
Alzheimer Disease, Dementia, Mild Cognitive Impairment, Cognitive Training, Serious Games
Brief summary
Today the therapy options for dementia due to Alzheimer's disease (AD) are limited. One recommended intervention is cognitive stimulation. We try to develop serious games as a further treatment option, also usable in pre-dementia as well as early stages of dementia and for a long period of time. The main objective of this study is to test, if the computerized-cognitive training (CCT) is able to improve the performance in a score quantifying an AD-specific component score. Additionally, the neurobiological effects of the training are investigated.
Detailed description
The study intervention consists of a computer-based cognitive training, targeting the cognitive domains mostly affected by AD. This training will be performed for three months (each day for 20 minutes). After three months the intervention group will continue the training at home for six months and meet monthly for group sessions (i.e. booster sessions) on site. Primary endpoint will be the change in an AD-specific component score, quantified by episodic memory, semantic memory and visuospatial abilities. Secondary endpoints are changes in task related brain networks and changes in resting state networks.
Interventions
DEVICEComputerized Cognitive Training
The study intervention consists of a tablet-based cognitive training, targeting the cognitive domains mostly affected by Alzheimer Disease.
DEVICEDocumentaries with delayed Computerized Cognitive Training
The active control group watches documentaries for three months before starting with the CCT.
Sponsors
University of Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomly assigned to one of three study arms and conduct a Computerized Cognitive Training (CCT) at home (daily) and on site (weekly) for 10 weeks. Before and after the CCT, neuropsychological assessments will be conducted.
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of Alzheimer's Disease * Patients with increased risk for developing dementia * Must be able to give their consent
Exclusion criteria
* Contra-indications for MRI scanning * Substance abuse * Severe medical conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in AD specific component score | The primary endpoint will be assessed four times, with breaks of three months in between. Primary outcome will be assessed up to 9 months. | The outcome is quantified by an AD component score including measures of EM (auditory verbal learning), SM (verbal fluency, naming task) and spatial abilities (Rey-Osterrieth complex figure test). These scores will be assessed four times, before the training as well as after three, six and nine months by tablet-based cognitive tests. A short follow-up assessment will be performed after a total of 12 months which does not include primary outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRI functional and structural | Secondary endpoints will be assessed two to four times, depending on the study arm, as MRI assessments are not always performed after six and nine months. | Secondary endpoints are changes in task related brain networks (i.e. spatial ability and episodic memory) and changes in resting state networks. |
Countries
Switzerland
Outcome results
None listed