Summary

for people ages 55-89 (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

Summary

Older adults at risk for dementia show a variety of cognitive deficits, which can be ameliorated by different cognitive training (CT) exercises. The best combination of CT exercises is unknown. The aim is to discover the most efficacious combination of CT exercises as compared to cognitive stimulation (which will serve as a stringent, active control) to modify the functional trajectories of older adults' with MCI, who are at high risk for dementia. The primary objective is to design and pilot-test an adaptive, randomized clinical trial (RCT) of cognitive training (CT) combinations aimed to enhance performance of instrumental activities of daily living (IADL) among persons with mild cognitive impairment (MCI). The longitudinal endpoint goal is delaying dementia onset. The primary aim of the study is to determine which CT combination has the best probability to delay dementia by producing the largest IADL improvements. The study further aims to explore the effects of CT on neuroimaging and novel blood-based biomarker outcomes.

Official Title

Planning an Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia: The ACTIVE MIND Trial

Details

Planning an Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia: The ACTIVE MIND Trial.

The primary objective is to design and pilot-test an adaptive, randomized clinical trial (RCT) of cognitive training (CT) combinations aimed to enhance performance of instrumental activities of daily living (IADL) among persons with mild cognitive impairment (MCI). The longitudinal endpoint goal is delaying dementia onset.

The secondary objectives are:

  • To pilot test a plan to recruit and enroll under-represented minorities with the goal of obtaining a sample representative of the USF population in race and ethnicity.
  • To explore blood-based biomarkers as outcomes of CT
  • To explore change in the Alzheimer's Disease Neuroimaging Initiative 3 (ADNI-3) MRI protocol for neuroimaging to quantify brain structure, white matter hyperintensities (WMH), hippocampal size, cerebral microbleed and perfusion, white matter integrity, and resting state function as an effect of CT interventions.

With additional funding and extension of the study:

  • To examine the efficacy of promising combinations of CT exercises to modify functional trajectories in MCI
  • To examine the efficacy of promising combinations of CT to delay dementia onset

Design: The design is an adaptive randomized trial to identify the best combination of CT exercises to improve IADL function and thereby delay dementia onset among persons with MCI. Four arms of CT will be compared to an active control condition.

Outcomes: Determine which combinations of CT are efficacious to improve IADL performance, and thereby most likely to delay dementia onset.

Everyday Function measures will include: Timed Instrumental Activities of Daily Living and iFunction. A composite of performance (measured by time and accuracy) will be derived from principal component analyses.

Cognition measures will include: Useful Field of View test (UFOV), Graduated Continuous Performance Test (gradCPT), and Examiner. A composite will be derived from principal component analyses.

Interventions and Duration Four combinations of computerized cognitive training and an active control computerized stimulation will be investigated. The five arms will be equivalent in terms of frequency and duration of each session (60 min/day, two-three days/wk, 16 weeks).

Sample size: In-person screening of 100 potential study participants are planned to enroll up to 60 participants. The goal is to have at least 60 participants complete the study. Individuals with a clinical diagnosis of MCI will be included in the study.

Keywords

Age-related Cognitive Decline Mild Cognitive Impairment Dementia Cognitive Dysfunction Cognitive Training Computerized Cognitive Stimulation CTa CTab CTac CTabc

Eligibility

You can join if…

Open to people ages 55-89

  • 55 to 89 years of age
  • Montreal Cognitive Assessment Score of 18-27 inclusive
  • History of some change in cognitive function relative to established baseline and either 1) a CDR of 0.5; or 2) CDR of 0 and a clinical diagnosis of mild cognitive impairment (MCI) based on a multidisciplinary evaluation that included standardized neuropsychological testing
  • If reports use of medications typically prescribed for dementia such as Namenda, Memantine, Namzaric, Donepezil, Aricept, Rivastigmine, Exelon, Razadyne, Galantamine, or Reminyl, dose has been stable for at least 30 days
  • Adequate auditory capacity to understand normal speech. No greater than moderate hearing loss evident by thresholds less than or equal to 50 dB at 1000 and 2000 Hz in at least one ear determined by an audioscope.
  • Adequate visual capacity to read from a computer screen at a normal viewing distance as measured by binocular visual acuity of 20/50 or better tested with a standard near visual acuity chart
  • Reports and shows adequate motor capacity to touch a computer screen or control a computer mouse.
  • Wiling to complete all study activities
  • Willing and capable of providing informed consent
  • Ability to understand study procedures and comply with them for the length of the study

You CAN'T join if...

  • Currently enrolled in another randomized clinical trial, treatment trial, or another research study that assesses cognition
  • Dementia diagnosis
  • Clinical Dementia Rating Scale of 1 or greater
  • History of large vessel stroke with significant residual motor or cognitive impairment
  • History of moderate to severe traumatic brain injury with residual cognitive symptoms
  • History of brain tumor
  • Undergoing or plans to undergo surgery requiring anesthesia, chemotherapy, or radiation treatment in the six months following screening
  • Congestive heart failure diagnosis
  • Primary diagnosis of idiopathic Parkinson's disease
  • Multiple sclerosis or Amyotrophic lateral sclerosis (ALS) diagnosis
  • Evidence of a non-neurodegenerative neurological disorder that would interfere with the ability to carry out study activities.
  • Evidence of any other unstable medical conditions that would interfere with the ability to carry out study activities or cause fluctuations in cognition (e.g., unstable diabetes, chronic obstructive pulmonary disorder dependent on oxygen)
  • Geriatric Depression short scale score >5/15. Participants with mood disorders that are treated and stable and have a GDS score < 6/15 are not excluded.
  • Any other clinically significant or unstable medical condition (e.g., ongoing alcohol dependency or drug abuse, schizophrenia, psychosis) that in the assessor's opinion would interfere with the ability to carry out study activities.
  • Previous participation in 10 or more hours of a computerized cognitive intervention program in the past two years
  • Previous participation in cognitive intervention research at the study site in the past 2 years
  • Planning on going away or being otherwise unavailable for a period of more than three weeks in the six months following screening
  • Contraindications to MRI such as pacemaker, metal implants in body, or claustrophobia

Locations

  • University of California San Francisco not yet accepting patients
    San Francisco California 94158 United States
  • University of Minnesota in progress, not accepting new patients
    Minneapolis Minnesota 55455 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of South Florida
ID
NCT04171323
Study Type
Interventional
Last Updated