REACT MCI - Repeated Advanced Cognitive Training in Mild Cognitive Impairment

Sorlandet Hospital HF

Status: Active, not recruiting

Conditions: Mild Cognitive Impairment

Treatments: Other: Computerized cognitive training.; Other: Generalized brain training / Active control

Study type: Interventional

Funder types: Other

Identifiers

NCT04792528

77084 REACT MCI

Prosjektnr. 2019208 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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205 participants in 3 patient groups

One training period

Experimental group

Description:

One training period of 30 minutes of daily adaptive training for 4-5 days a week up for 20- 25 trainings using computerized cognitive training.

Treatment:

Other: Computerized cognitive training.

Two training periods

Experimental group

Description:

Two training periods of 30 minutes of daily adaptive training for 4-5 days a week up for 20- 25 trainings using computerized cognitive training.

Treatment:

Other: Computerized cognitive training.

Active control

Active Comparator group

Description:

The generalized brain training group (Active control) will play solitaire 30 minutes daily for 25 sessions

Treatment:

Other: Generalized brain training / Active control