REACT MCI - Repeated Advanced Cognitive Training in Mild Cognitive Impairment

NCT ID: NCT04792528

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2028-10-25

Brief Summary

Background:

Dementia is a debilitating and devastating disease impacting the individuals, their families, and the health care system. According to the World Health Organization the dementia epidemic could overwhelm the global health care system and undermine social and economic development. Currently, no curative treatment for dementia exists despite immense research activity.

The cognitive and functional impairment in dementia, especially Alzheimer's disease (AD), develop slowly decades before clinical signs emerge. This knowledge has led to the recognition of a prodromal period of mild cognitive impairment (MCI), between normal cognition and dementia. This is at present the earliest stage for intervention in dementia; even a short delay in dementia progression will have a large impact on global economy and health care.

Objectives:

In this clinical multicenter study, we aim to investigate the efficiency and cost-effectiveness of working memory training in MCI. To identify high responders to training analysis of genetic markers, relative's stress and craniospinal clearance will be performed.

Participants and methods:

This study is a blinded, randomized and controlled trail that will include 213 participants, diagnosed with MCI, included from five Norwegian Memory clinics in four health care regions. The groups will be randomized to either two training periods, one training period or active control. The intervention is computerized working memory training. Neuropsychological status, activities of daily living (ADL), and relative stress and quality of life will be assessed at baseline and 3, 6, 12 ,24 and 48 months after training. Structural MRI will be performed at baseline, and 3 and 6 months after training.

For participants in the REACT MCI glymphatics substudy craniospinal clearance will be measured at baseline.

A cost-utility analysis will be performed to evaluate if the working memory training is more cost-effective compared to the active control group in the MCI phase, taking a societal perspective.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

One training period

One training period of 30 minutes of daily adaptive training for 4-5 days a week up for 20- 25 trainings using computerized cognitive training.

Group Type: EXPERIMENTAL

Computerized cognitive training.

Intervention Type: OTHER

COGMED RM program (Pearson Inc., UK)

Two training periods

Two training periods of 30 minutes of daily adaptive training for 4-5 days a week up for 20- 25 trainings using computerized cognitive training.

Group Type: EXPERIMENTAL

Computerized cognitive training.

Intervention Type: OTHER

COGMED RM program (Pearson Inc., UK)

Active control

The generalized brain training group (Active control) will play solitaire 30 minutes daily for 25 sessions

Group Type: ACTIVE_COMPARATOR

Generalized brain training / Active control

Intervention Type: OTHER

Solitaire

Interventions

Computerized cognitive training.

COGMED RM program (Pearson Inc., UK)

Intervention Type: OTHER

Generalized brain training / Active control

Solitaire

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of MCI, based on the Mayo/winblad criteria or confirmation of current MCI status within the last 6 months before study enrollment.
• The ability to use and accessibility to an iPad or computer.
• Fluent in Norwegian.
• Spinal tap performed and results available

• Enrollment in the REACT MCI study
• Participant allocated to Sorlandet Hospital or Oslo University Hospital

Exclusion Criteria

• Patients unable to undergo a MRI investigation based on claustrophobia or metal foreign bodies are excluded from the study.
• Major psychiatric illness and current substance abuse
• Recent stroke

• Individuals with known allergy against contrast solutions
• Individuals with other serious allergies
• Individuals with kidney failure or glomerular filtration rate < 30
• Individuals younger than 18 or older than 80
• Pregnant or lactating women
• For individuals >70 years or with medications affecting kidney function the glomerular filtration rate needs to be less than week old.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

NKS Olaviken

UNKNOWN

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

NKS Kloverasen

UNKNOWN

Sponsor Role: collaborator

Barrow Neurological Institute

OTHER

Sponsor Role: collaborator

University of Maryland

OTHER

Sponsor Role: collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susanne S Hernes, M.D. Phd.

Role: PRINCIPAL_INVESTIGATOR

Sørlandet Sykehus HF, Universitetet i Bergen

Locations

Sørlandet Sykehus Arendal

Arendal, , Norway

NKS Olaviken Alderspsykiatriske sykehus - Hukommelsesklinikk

Bergen, , Norway

N.K.S. Kløveråsen

Bodø, , Norway

Oslo Universitetssykehus Ullevål

Oslo, , Norway

St. Olavs Hospital

Trondheim, , Norway

Countries

Norway

Other Identifiers

Prosjektnr. 2019208

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

77084 REACT MCI

Identifier Type: -

Identifier Source: org_study_id