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ACTIVE NOT RECRUITING
NCT04792528
NA

REACT MCI - Repeated Advanced Cognitive Training in Mild Cognitive Impairment

Sponsor: Sorlandet Hospital HF

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

205

Start Date

2021-05-15

Completion Date

2028-10-25

Last Updated

2025-06-05

Healthy Volunteers

No

Interventions

OTHER

Computerized cognitive training.

COGMED RM program (Pearson Inc., UK)

OTHER

Generalized brain training / Active control

Solitaire

Locations (5)

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