Tablet-based Cognitive Training

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04452864
• Other study ID #: 2020-00630
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: April 1, 2025

Study information

• Verified date: November 2023
• Source: University of Bern
• Contact: Esther Brill, M.Sc.
• Phone: +41 31 930 9634
• Email: esther.brill[@]unibe.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: April 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

Device:
• Computerized Cognitive Training
The study intervention consists of a tablet-based cognitive training, targeting the cognitive domains mostly affected by Alzheimer Disease.
• Documentaries with delayed Computerized Cognitive Training
The active control group watches documentaries for three months before starting with the CCT.

Locations

Country	Name	City	State
Switzerland	University Hospital of Old Age Psychiatry and Psychotherapy	Bern
Switzerland	Memory Clinic Zentralschweiz	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Brill E, Krebs C, Falkner M, Peter J, Henke K, Zust M, Minkova L, Brem AK, Kloppel S. Can a serious game-based cognitive training attenuate cognitive decline related to Alzheimer's disease? Protocol for a randomized controlled trial. BMC Psychiatry. 2022 Aug 12;22(1):552. doi: 10.1186/s12888-022-04131-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.