REACT MCI - Repeated Advanced Cognitive Training in Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

— REACT MCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04792528
• Other study ID #: 77084 REACT MCI
• Secondary ID: Prosjektnr. 2019
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: April 15, 2026

Study information

• Verified date: April 2024
• Source: Sorlandet Hospital HF
• Contact: Mona L Henriksen
• Phone: 004737075161
• Email: mona.lonebu.henriksen[@]sshf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 213
• Est. completion date: April 15, 2026
• Est. primary completion date: April 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Other:
• Computerized cognitive training.
COGMED RM program (Pearson Inc., UK)
• Generalized brain training / Active control
Solitaire

Locations

Country	Name	City	State
Norway	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

Sponsors (7)

Lead Sponsor	Collaborator
Sorlandet Hospital HF	Barrow Neurological Institute, NKS Kloverasen, NKS Olaviken, Oslo University Hospital, St. Olavs Hospital, University of Maryland

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Working memory training is superior to active control measured by spatial span backwards at 6 months		From enrollment until 6 months
Primary	Reduced function in the glymphatic system is associated with reduced working memory training effect measured by CT evaluated craniospinal clearance	Craniospinal clearance will be evaluated with a single CT image scan at level with the foramen magnum.	Enrollment to 12 months
Primary	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
Primary	Working memory training prolongs the MCI phase as compared to active controls	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.	Enrollment to 48 months
Secondary	The effect of working memory training is dose related measured by spatial span backwards after 6 months		Enrollment to 6 months
Secondary	Allelic variations in predefined genetic markes influence training effects after 3 months measured by spatial span backwards.	Allelic variations of LMX1a, APOE, AQP4 and/or COMT have in previous publications shown variable impact on working memory training. A statistical model combining these genes will be fitted for this investigation	Enrollment to 3 months
Secondary	Workin memory training reduces relatives stress scores as compared to relatives stress scores in the active control group after 12 months	Relatives stress score (RSS) is a validated scale measuring the stress for relatives	Enrollment to 12 months
Secondary	Working memory training reduces QALY associated cost as compared to active controls at 24 months.	The generic outcome in the analysis is QALYs (Quality adjusted life years) derived from the instrument EQ-5D 5L. The second outcome is production loss of the relatives and patients associated with MCI through the progression of dementia The health economic analysis will include following costs: 1) intervention related costs 2) direct costs/health care costs, mainly related to use of health care services, including primary, secondary and tertiary care and health services 3) indirect costs, including work absence for the patients and the relatives of the patients (i.e., productivity loss). Data will be collected through a self-report measures (EQ-5D 5L), and from the Norwegian patient registry.	Enrollment to 24 months
Secondary	Working memory training reduces QALY associated cost as compared to active controls at 48 months.	The generic outcome in the analysis is QALYs (Quality adjusted life years) derived from the instrument EQ-5D 5L. The second outcome is production loss of the relatives and patients associated with MCI through the progression of dementia The health economic analysis will include following costs: 1) intervention related costs 2) direct costs/health care costs, mainly related to use of health care services, including primary, secondary and tertiary care and health services 3) indirect costs, including work absence for the patients and the relatives of the patients (i.e., productivity loss). Data will be collected through a self-report measures (EQ-5D 5L), and from the Norwegian patient registry.	enrollment to 48 months