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Mild Cognitive ImpairmentREACT MCINCT04792528

REACT MCI - Repeated Advanced Cognitive Training in Mild Cognitive Impairment

A study testing Computerized cognitive training. in people with Mild Cognitive Impairment, run by Sorlandet Hospital HF at 5 sites in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Computerized cognitive training.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
205 participants
Where
5 sitesNorway
Study dates
15 May 2021to 25 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Norway5 sites

  • Sørlandet Sykehus Arendal

    Arendal

  • NKS Olaviken Alderspsykiatriske sykehus - Hukommelsesklinikk

    Bergen, 5009

  • N.K.S. Kløveråsen

    Bodø, 8076

  • Oslo Universitetssykehus Ullevål

    Oslo

  • St. Olavs Hospital

    Trondheim, 7006

Other trials in Norway

About this study

Official title: Repeated Advanced Cognitive Training in Mild Cognitive Impairment (The REACT MCI Study). A Randomized, Controlled Trial.

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.

Read more

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.

Being tested
Computerized cognitive training., Generalized brain training / Active control
Keywords
computer-based cognitive training
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computerized cognitive training.Other

    COGMED RM program (Pearson Inc., UK)

  • Generalized brain training / Active controlOther

    Solitaire

Study groups in NCT04792528
Study groupRoleWhat they receive
One training periodExperimentalOne training period of 30 minutes of daily adaptive training for 4-5 days a week up for 20- 25 trainings using computerized cognitive training.
Receives: Other: Computerized cognitive training.
Two training periodsExperimentalTwo training periods of 30 minutes of daily adaptive training for 4-5 days a week up for 20- 25 trainings using computerized cognitive training.
Receives: Other: Computerized cognitive training.
Active controlActive comparatorThe generalized brain training group (Active control) will play solitaire 30 minutes daily for 25 sessions
Receives: Other: Generalized brain training / Active control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Working memory training is superior to active control measured by spatial span backwards at 6 months

    Measured: From enrollment until 6 months

  2. Reduced function in the glymphatic system is associated with reduced working memory training effect measured by CT evaluated craniospinal clearance

    Craniospinal clearance will be evaluated with a single CT image scan at level with the foramen magnum.

    Measured: Enrollment to 12 months

  3. Working memory training impact quality of life measure in the participants as compared to active control measured by EuroQOL5D-5L after 12 months.

    Measured: Enrollment to12 months

  4. Working memory training prolongs the MCI phase as compared to active controls

    We consider the participants as having dementia when they no longer rapport intact activities of daily living and in addition display reduction of 1.5 standard deviation on test score on two tests on three or more cognitive domains.

    Measured: Enrollment to 48 months

Secondary outcomes (5)

  1. The effect of working memory training is dose related measured by spatial span backwards after 6 months

    Measured: Enrollment to 6 months

  2. Allelic variations in predefined genetic markes influence training effects after 3 months measured by spatial span backwards.

    Allelic variations of LMX1a, APOE, AQP4 and/or COMT have in previous publications shown variable impact on working memory training. A statistical model combining these genes will be fitted for this investigation

    Measured: Enrollment to 3 months

  3. Workin memory training reduces relatives stress scores as compared to relatives stress scores in the active control group after 12 months

    Relatives stress score (RSS) is a validated scale measuring the stress for relatives

    Measured: Enrollment to 12 months

  4. Working memory training reduces QALY associated cost as compared to active controls at 24 months.

    The generic outcome in the analysis is QALYs (Quality adjusted life years) derived from the instrument EQ-5D 5L. The second outcome is production loss of the relatives and patients associated with MCI through the progression of dementia The health economic analysis will include following costs: 1) intervention related costs 2) direct costs/health care costs, mainly related to use of health care services, including primary, secondary and tertiary care and health services 3) indirect costs, including work absence for the patients and the relatives of the patients (i.e., productivity loss). Data will be collected through a self-report measures (EQ-5D 5L), and from the Norwegian patient registry.

    Measured: Enrollment to 24 months

  5. Working memory training reduces QALY associated cost as compared to active controls at 48 months.

    The generic outcome in the analysis is QALYs (Quality adjusted life years) derived from the instrument EQ-5D 5L. The second outcome is production loss of the relatives and patients associated with MCI through the progression of dementia The health economic analysis will include following costs: 1) intervention related costs 2) direct costs/health care costs, mainly related to use of health care services, including primary, secondary and tertiary care and health services 3) indirect costs, including work absence for the patients and the relatives of the patients (i.e., productivity loss). Data will be collected through a self-report measures (EQ-5D 5L), and from the Norwegian patient registry.

    Measured: enrollment to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2021
  2. Study start15 May 2021
  3. Primary completion15 Apr 2028 (estimated)
  4. Study completion25 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomization in blocks of six to eight will be performed by the regional research support statistics service to either two training periods, one training period or generalized brain training/active control.
Masking
Single blind
Who is masked
Investigator
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04792528
Sponsor's protocol ID
77084 REACT MCI
Other IDs
Prosjektnr. 2019208
Acronym
REACT MCI
Status last verified
Apr 2026
First submitted
23 Feb 2021
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hernes SS, Nordnes PR, Hol HR, Ringstad G, Knapskog AB, Emhjellen P, Lohaugen G, Emini M, Edwin TH. The REACT MCI study: a randomized controlled clinical trial on the effect of repeated advanced cognitive training in mild cognitive impairment. Trials. 2026 May 7;27(1):363. doi: 10.1186/s13063-026-09711-6.

    PubMed 42098801

Questions about this trial

What is this clinical trial studying?

A study testing Computerized cognitive training. in people with Mild Cognitive Impairment, run by Sorlandet Hospital HF at 5 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Working memory training is superior to active control measured by spatial span backwards at 6 months (time frame: From enrollment until 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04792528, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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