Tablet-based Cognitive Training

January 8, 2025 updated by: University of Bern

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3000
        • University Hospital of Old Age Psychiatry and Psychotherapy
      • Luzern, Switzerland, 6000
        • Memory Clinic Zentralschweiz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Intervention
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
The study intervention consists of a tablet-based cognitive training, targeting the cognitive domains mostly affected by Alzheimer Disease.
Active Comparator: Active Control Group
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
The active control group watches documentaries for three months before starting with the CCT.
Other: Wait-List Control
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
The study intervention consists of a tablet-based cognitive training, targeting the cognitive domains mostly affected by Alzheimer Disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in AD specific component score
Time Frame: 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.
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
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Investigators

  • Principal Investigator: Stefan Klöppel, Prof. Dr., University of Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

July 9, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

June 24, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (Actual)

July 1, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-00630

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication will be published pseudonymized in a open access data base

IPD Sharing Time Frame

IPD and any additional material will be available when data collection and analysis is completed Items will be retained for the lifetime of the repository (at least 20years)

IPD Sharing Access Criteria

According to SNF Guidelines IPD will be published in a open access data base

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dementia

Clinical Trials on Computerized Cognitive Training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe