REACT MCI - Repeated Advanced Cognitive Training in Mild Cognitive Impairment

Condition(s) studied

Investigational drug(s) / intervention(s)

Computerized cognitive training.: COGMED RM program (Pearson Inc., UK)

Generalized brain training / Active control: Solitaire

Study 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.

Eligibility

Primary outcome measure(s)

• 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 — Enrollment to 12 months
  Craniospinal clearance will be evaluated with a single CT image scan at level with the foramen magnum.
• 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 — Enrollment to 48 months
  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.

Trial sites (5)

More Sorlandet Hospital HF trials in Norway

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