REACT MCI - Repeated Advanced Cognitive Training in Mild Cognitive Impairment

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

Interventions

OTHER

Computerized cognitive training.

COGMED RM program (Pearson Inc., UK)

OTHER

Generalized brain training / Active control

Solitaire

Sponsors & Collaborators

• Oslo University Hospital

  collaborator OTHER

• NKS Olaviken

  collaborator UNKNOWN

• St. Olavs Hospital

  collaborator OTHER

• NKS Kloverasen

  collaborator UNKNOWN

• Barrow Neurological Institute

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• Sorlandet Hospital HF

  lead OTHER_GOV

Principal Investigators

• Susanne S Hernes, M.D. Phd. · Sørlandet Sykehus HF, Universitetet i Bergen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-15

Primary Completion

2028-04-15

Completion

2028-10-25

Countries

• Norway

Study Locations