Tablet-based Cognitive Training

Study Overview
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Brief Summary
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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
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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.

Official Title
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Can a Serious Game-based Cognitive Training Attenuate Cognitive Decline Related to Alzheimer's Disease

Conditions
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Alzheimer Disease, Dementia, Mild Cognitive Impairment

Intervention / Treatment
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* Device: Computerized Cognitive Training
* Device: Documentaries with delayed Computerized Cognitive Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Intervention<br>The study intervention consists of a tablet-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 this group will continue the training at home for six months and meet monthly for group sessions (i.e. booster sessions) on site. | Device: Computerized Cognitive Training<br>* The study intervention consists of a tablet-based cognitive training, targeting the cognitive domains mostly affected by Alzheimer Disease.<br>|
| Active Comparator: Active Control Group<br>This control study arm will watch documentaries at home for three months (each day for 20 minutes) , instead of performing the CCT and serve as active control group. This group will also train with the CCT tasks after these three months. | Device: Documentaries with delayed Computerized Cognitive Training<br>* The active control group watches documentaries for three months before starting with the CCT.<br>|
| Other: Wait-List Control<br>This control study arm will start with the CCT with a delay of three months and serve as wait-list control group. | Device: Computerized Cognitive Training<br>* The study intervention consists of a tablet-based cognitive training, targeting the cognitive domains mostly affected by Alzheimer Disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AD specific component score | 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. | The primary endpoint will be assessed four times, with breaks of three months in between. Primary outcome will be assessed up to 9 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI functional and structural | Secondary endpoints are changes in task related brain networks (i.e. spatial ability and episodic memory) and changes in resting state networks. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer Disease, Dementia, Mild Cognitive Impairment, Cognitive Training, Serious Games