Tablet-based Cognitive Training

NCT04452864 | Completed

• 1 other identifier: 2020-00630
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 2

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.

Conditions

Alzheimer Disease; Dementia; Mild Cognitive Impairment

Keywords

Alzheimer Disease; Dementia; Mild Cognitive Impairment; Cognitive Training; Serious Games

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (3)

Study Intervention

EXPERIMENTAL

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

Active Control Group

ACTIVE COMPARATOR

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

Wait-List Control

OTHER

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

Interventions

Computerized Cognitive Training DEVICE

The study intervention consists of a tablet-based cognitive training, targeting the cognitive domains mostly affected by Alzheimer Disease.

Study Intervention; Wait-List Control

Documentaries with delayed Computerized Cognitive Training DEVICE

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

Active Control Group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Alzheimer's Disease
• Patients with increased risk for developing dementia
• Must be able to give their consent

You may not qualify if:

• Contra-indications for MRI scanning
• Substance abuse
• Severe medical conditions

Sponsors & Collaborators

• University of Bern: lead

Study Sites (2)

University Hospital of Old Age Psychiatry and Psychotherapy

Bern, 3000, Switzerland

Location

Memory Clinic Zentralschweiz

Lucerne, 6000, Switzerland

Location

Related 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.

  PMID: 35962371 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Stefan Klöppel, Prof. Dr.

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 1, 2020
• Study Start: July 1, 2020
• Primary Completion: July 9, 2024
• Study Completion: October 31, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• 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)
• Access Criteria: According to SNF Guidelines IPD will be published in a open access data base

Locations

CH (2)