Tablet-based Cognitive Training

University of Bern

Status: Completed

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Dementia

Treatments: Device: Documentaries with delayed Computerized Cognitive Training; Device: Computerized Cognitive Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04452864

2020-00630

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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162 participants in 3 patient groups

Study Intervention

Experimental group

Description:

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.

Treatment:

Device: Computerized Cognitive Training

Active Control Group

Active Comparator group

Description:

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.

Treatment:

Device: Documentaries with delayed Computerized Cognitive Training

Wait-List Control

Other group

Description:

This control study arm will start with the CCT with a delay of three months and serve as wait-list control group.

Treatment:

Device: Computerized Cognitive Training