REACT MCI - Repeated Advanced Cognitive Training in Mild Cognitive Impairment

NCT04792528 | Active Not Recruiting

• 2 other identifiers: 77084 REACT MCIProsjektnr. 2019208
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 5

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

Keywords

computer-based cognitive training

Outcome Measures

Primary Outcomes (4)

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

  From enrollment until 6 months

• 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.

  Enrollment to 12 months

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

  Enrollment to12 months

• 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.

  Enrollment to 48 months

Secondary Outcomes (5)

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

  Enrollment to 6 months

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

  Enrollment to 3 months

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

  Enrollment to 12 months

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

  Enrollment to 24 months

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

  enrollment to 48 months

Study Arms (3)

One training period

EXPERIMENTAL

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.

Other: Computerized cognitive training.

Two training periods

EXPERIMENTAL

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.

Other: Computerized cognitive training.

Active control

ACTIVE COMPARATOR

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

Other: Generalized brain training / Active control

Interventions

Computerized cognitive training. OTHER

COGMED RM program (Pearson Inc., UK)

One training period; Two training periods

Generalized brain training / Active control OTHER

Solitaire

Active control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sorlandet Hospital HF: lead
• Oslo University Hospital: collaborator
• NKS Olaviken: collaborator
• St. Olavs Hospital: collaborator
• NKS Kloverasen: collaborator
• Barrow Neurological Institute: collaborator
• University of Maryland: collaborator

Study Sites (5)

Sørlandet Sykehus Arendal

Arendal, Norway

Location

NKS Olaviken Alderspsykiatriske sykehus - Hukommelsesklinikk

Bergen, 5009, Norway

Location

N.K.S. Kløveråsen

Bodø, 8076, Norway

Location

Oslo Universitetssykehus Ullevål

Oslo, Norway

Location

St. Olavs Hospital

Trondheim, 7006, Norway

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Susanne S Hernes, M.D. Phd.

  Sørlandet Sykehus HF, Universitetet i Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: All study personnel except for the PI, coaches and Study secretary will be blinded for group allocation regarding types of memory training.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 11, 2021
• Study Start: May 15, 2021
• Primary Completion (Estimated): April 15, 2028
• Study Completion (Estimated): October 25, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (5)