Clinical trial NCT04792528: REACT MCI - Repeated Advanced Cognitive Training in Mild Cognitive Impairment
Official title: Repeated Advanced Cognitive Training in Mild Cognitive Impairment (The REACT MCI Study). A Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: computer-based cognitive training
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: Oslo University Hospital
name: NKS Olaviken
name: St. Olavs Hospital
name: NKS Kloverasen
name: Barrow Neurological Institute
name: University of Maryland
First posted: 2021-03-11
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization in blocks of six to eight will be performed by the regional research support statistics service to either two training periods, one training period or generalized brain training/active control.
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Working memory training is superior to active control measured by spatial span backwards at 6 months
timeFrame: From enrollment until 6 months
measure: Reduced function in the glymphatic system is associated with reduced working memory training effect measured by CT evaluated craniospinal clearance
timeFrame: Enrollment to 12 months
measure: Working memory training impact quality of life measure in the participants as compared to active control measured by EuroQOL5D-5L after 12 months.
timeFrame: Enrollment to12 months
measure: Working memory training prolongs the MCI phase as compared to active controls
timeFrame: Enrollment to 48 months
Secondary outcomes:
measure: The effect of working memory training is dose related measured by spatial span backwards after 6 months
timeFrame: Enrollment to 6 months
measure: Allelic variations in predefined genetic markes influence training effects after 3 months measured by spatial span backwards.
timeFrame: Enrollment to 3 months
measure: Workin memory training reduces relatives stress scores as compared to relatives stress scores in the active control group after 12 months
timeFrame: Enrollment to 12 months
measure: Working memory training reduces QALY associated cost as compared to active controls at 24 months.
timeFrame: Enrollment to 24 months
measure: Working memory training reduces QALY associated cost as compared to active controls at 48 months.
timeFrame: enrollment to 48 months
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Sørlandet Sykehus Arendal
city: Bergen
country: Norway
facility: NKS Olaviken Alderspsykiatriske sykehus - Hukommelsesklinikk
city: Bodø
country: Norway
facility: N.K.S. Kløveråsen
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Ullevål
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: Sørlandet Sykehus HF, Universitetet i Bergen
name: Susanne S Hernes, M.D. Phd.
role: PRINCIPAL_INVESTIGATOR
References: