Clinical trial NCT04452864: Tablet-based Cognitive Training
Official title: Can a Serious Game-based Cognitive Training Attenuate Cognitive Decline Related to Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Mild Cognitive Impairment
Keywords: Alzheimer Disease
Dementia
Mild Cognitive Impairment
Cognitive Training
Serious Games
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 162
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of three study arms and conduct a Computerized Cognitive Training (CCT) at home (daily) and on site (weekly) for 10 weeks. Before and after the CCT, neuropsychological assessments will be conducted.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in AD specific component score
timeFrame: 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 outcomes:
measure: MRI functional and structural
timeFrame: 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.
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital of Old Age Psychiatry and Psychotherapy
city: Luzern
country: Switzerland
facility: Memory Clinic Zentralschweiz
Study officials:
affiliation: University of Bern
name: Stefan Klöppel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.