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REACT MCI - Repeated Advanced Cognitive Training in Mild Cognitive Impairment

Study acronym: REACT MCI
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Apr 15, 2026 to Apr 15, 2028v6
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 213 to confirmed 205
    • Study completion date: Apr 15, 2026 to Oct 25, 2028
    • Site details revised at 5 of 5 sites
    v5
  3. Minor Re-verified, no change to tracked fieldsv4
  4. Notable Lead sponsor: Susanne Sørensen Hernes to Sorlandet Hospital HF
    • Collaborators revised (6)
    v3
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 5 of 5 sites
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04792528
Lead Sponsor Sorlandet Hospital HF
Collaborators: Oslo University Hospital, NKS Olaviken, St. Olavs Hospital, NKS Kloverasen, Barrow Neurological Institute, University of Maryland
Conditions
(from sponsor)
Mild Cognitive Impairment
Related terms Cognitive Dysfunction
Enrollment 205 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov