Tablet-based Cognitive Training

Not Applicable

Completed

• Conditions: Alzheimer Disease; Mild Cognitive Impairment; Dementia
• Interventions: Device: Documentaries with delayed Computerized Cognitive Training; Device: Computerized Cognitive Training

• Registration Number: NCT04452864
• Lead Sponsor: University of Bern

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.

Study Timeline

• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-06-29
• Study Start: 2020-07-01
• Study First Posted: 2020-07-01
• Primary Completion: 2024-07-09
• Study Completion: 2024-10-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Control Group	Documentaries with delayed Computerized Cognitive Training	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.
Study Intervention	Computerized Cognitive Training	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.
Wait-List Control	Computerized Cognitive Training	This control study arm will start with the CCT with a delay of three months and serve as wait-list control group.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

University Hospital of Old Age Psychiatry and Psychotherapy; 🇨🇭 Bern, Switzerland

Memory Clinic Zentralschweiz; 🇨🇭 Luzern, Switzerland