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OpenTrials
Completed

NCT Number: NCT04452864

Tablet-based Cognitive Training

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Old Age Psychiatry and Psychotherapy, Bern, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computerized Cognitive Training

Device

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

Device

The active control group watches documentaries for three months before starting with the CCT.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 1, 2020
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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