Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Norway / NCT04792528
Active, not recruiting Not applicable

REACT MCI - Repeated Advanced Cognitive Training in Mild Cognitive Impairment

NCT04792528 · tracked via the Priya Life Science Norway tracker
Sponsor
Sorlandet Hospital HF
Phase
Not applicable
Started
2021-05-15
Last updated
2026-04-30

Condition(s) studied

Mild Cognitive Impairment

Investigational drug(s) / intervention(s)

Computerized cognitive training.Generalized brain training / Active control

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria for the REACT MCI study: * 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 Exclusion Criteria for the REACT MCI study: * 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 Inclusion Criteria for the REACT MCI Glymphatics substudy: * Enrollment in the REACT MCI study * Participant allocated to Sorlandet Hospital or Oslo University Hospital Exclusion Criteria for the REACT MCI Glymphatics substudy: * 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.

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)

FacilityCityRegionStatus
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

More Sorlandet Hospital HF trials in Norway

Surgical Approach in Hemiarthroplasty. A Randomized Clinical Trial Comparing Posterior and Anterior Approach Active, not recruiting
The Southern-Norway Post-Stroke Atrial Fibrillation Study Recruiting
Where Wild Things Grow: Nature- and Activity-based Group Interventions for Neurodivergent Children and Youth Recruiting
Establishing Mechanical Thrombectomy at a Limited-volume Stroke Center - Effects on Patient Morbidity and Mortality Recruiting
Psychoeducation of Parents to Children With FASD Recruiting

Other trials for the same condition

Akershus Cardiac Examination (ACE) 1950 Study Active, not recruiting
Multimodal Assesment of Alzheimer Patients Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04792528 on ClinicalTrials.gov ↗ ← All trials in Norway