Preventing Alzheimer's Disease With Cognitive Training
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 3/21/2019 |
| Start Date: | February 19, 2019 |
| End Date: | June 30, 2020 |
| Contact: | Jerri Edwards, PhD |
| Email: | usftampapact@gmail.com |
| Phone: | 813.974.8572 |
Preventing Alzheimer's Disease With Cognitive Training: The PACT Trial
Dementia is the most expensive medical condition in the US and increases in prevalence with
age. More than 5 million Americans have Alzheimer's disease, the most common form of
dementia. Mild cognitive impairment is a transitional stage between normal cognitive aging
and Alzheimer's disease or another type of dementia, and is indicative of higher risk for
dementia. In addition to the obvious health and quality-of-life ramifications of dementia,
there are high direct (e.g., subsidizing residential care needs) and indirect (e.g., lost
productivity of family caregivers) economic costs. Implementing interventions to prevent MCI
and dementia among older adults is of critical importance to health and maintained
quality-of-life for millions of Americans. Recent data analyses from the Advanced Cognitive
Training in Vital Elderly study (ACTIVE) indicate that a specific cognitive intervention,
speed of processing training (SPT), significantly delays the incidence of cognitive
impairment across 10 years. The primary contribution of the proposed research will be the
determination of whether this cognitive training technique successfully delays the onset of
clinically defined MCI or dementia across three years.
age. More than 5 million Americans have Alzheimer's disease, the most common form of
dementia. Mild cognitive impairment is a transitional stage between normal cognitive aging
and Alzheimer's disease or another type of dementia, and is indicative of higher risk for
dementia. In addition to the obvious health and quality-of-life ramifications of dementia,
there are high direct (e.g., subsidizing residential care needs) and indirect (e.g., lost
productivity of family caregivers) economic costs. Implementing interventions to prevent MCI
and dementia among older adults is of critical importance to health and maintained
quality-of-life for millions of Americans. Recent data analyses from the Advanced Cognitive
Training in Vital Elderly study (ACTIVE) indicate that a specific cognitive intervention,
speed of processing training (SPT), significantly delays the incidence of cognitive
impairment across 10 years. The primary contribution of the proposed research will be the
determination of whether this cognitive training technique successfully delays the onset of
clinically defined MCI or dementia across three years.
Preventing Alzheimer's Disease with Cognitive Training: The PACT Trial
The primary objective is to establish the feasibility of the proposed field trial including
meeting participant enrollment goals. The feasibility of the field trial will be established
by identifying enrollment sites, hiring and training staff in study protocols and standard
operating procedures, developing marketing tools, and initiating recruitment. The enrollment
goal is to accrue 1600 participants within 1 year of starting data collection.
The secondary objective is to ascertain participants' willingness to enroll in a longitudinal
clinical trial and to subsequently complete a multispecialty clinical diagnostic evaluation,
psychometric testing, MRI, PET scan, and genetic testing. Participants' willingness to allow
access to medicare records will also be determined.
If the trial is funded and extended into a longitudinal study, the primary goal of the
subsequent trial will be to ascertain the effectiveness of cognitive speed of processing
training (SPT) to reduce the incidence of MCI or dementia.
Design and Outcomes: A pilot randomized clinical trial among 1600 adults 65 years of age and
older will be completed in order to demonstrate the feasibility of conducting a larger trial
designed to test the effectiveness of computerized cognitive speed of processing training
(SPT) to reduce incidence of Mild Cognitive Impairment (MCI) or dementia.
Participants will be screened with an inclusion/exclusion questionnaire and those potentially
eligible will complete brief memory screening, depression screening, and other
questionnaires. Those eligible will be randomized to either cognitive speed of processing
training (SPT) or an active control condition (computer games) and will complete at least
three in-person, supervised training sessions. Additional exercises will be completed at-home
over the next 3 to 5 months followed by booster sessions 1- and 2-years later. Participants'
willingness to enroll in a longitudinal trial and to subsequently complete a multispecialty
clinical diagnostic evaluation, MRI, psychometric testing, PET scan, genetic testing, and to
allow access to Medicare records will be assessed.
Interventions and Duration: The intervention is computerized cognitive speed of processing
training (SPT), which is also known as Useful Field of View (UFOV) training. SPT enhances
cognition through practice of adaptive exercises of perceptual processing. The goal of the
exercises is to increase the amount of information one can quickly process. SPT exercises are
designed to improve UFOV performance. A novel training exercise, recently shown to produce
larger UFOV gains (the proximal outcome of SPT), tonic and phasic alertness is also included.
Tonic and phasic alertness training improves attention, executive function and learning in
older adults. The exercise requires users to remain alert and engaged (tonic alertness) by
responding quickly to all target images and inhibiting response (phasic alertness) to random,
infrequent foils.
An active control condition of cognitive stimulation (i.e., computer games) is included. The
exercises are based upon correlational research that cognitively-stimulating leisure
activities can maintain cognition with increasing age. The control condition will be composed
of commercially available computer games (e.g., Sudoku, crossword puzzles) and is designed to
match SPT with the expectation-based influence on cognitive performance, intensity, and
overall engagement.
Participants will initially complete 25 sessions of training and will complete an additional
10 sessions of booster training 1- and 2- years later. Participants will first be instructed
to complete 2-3 sessions of training per week until 25 sessions are completed. At 1- year and
again at 2-years, participants will be instructed to complete an additional 10 sessions of
training.
Sample Size and Population: Adults 65 years of age and older (N=1600) will be randomly
assigned to SPT (n=800) or the control condition (n=800).
The primary objective is to establish the feasibility of the proposed field trial including
meeting participant enrollment goals. The feasibility of the field trial will be established
by identifying enrollment sites, hiring and training staff in study protocols and standard
operating procedures, developing marketing tools, and initiating recruitment. The enrollment
goal is to accrue 1600 participants within 1 year of starting data collection.
The secondary objective is to ascertain participants' willingness to enroll in a longitudinal
clinical trial and to subsequently complete a multispecialty clinical diagnostic evaluation,
psychometric testing, MRI, PET scan, and genetic testing. Participants' willingness to allow
access to medicare records will also be determined.
If the trial is funded and extended into a longitudinal study, the primary goal of the
subsequent trial will be to ascertain the effectiveness of cognitive speed of processing
training (SPT) to reduce the incidence of MCI or dementia.
Design and Outcomes: A pilot randomized clinical trial among 1600 adults 65 years of age and
older will be completed in order to demonstrate the feasibility of conducting a larger trial
designed to test the effectiveness of computerized cognitive speed of processing training
(SPT) to reduce incidence of Mild Cognitive Impairment (MCI) or dementia.
Participants will be screened with an inclusion/exclusion questionnaire and those potentially
eligible will complete brief memory screening, depression screening, and other
questionnaires. Those eligible will be randomized to either cognitive speed of processing
training (SPT) or an active control condition (computer games) and will complete at least
three in-person, supervised training sessions. Additional exercises will be completed at-home
over the next 3 to 5 months followed by booster sessions 1- and 2-years later. Participants'
willingness to enroll in a longitudinal trial and to subsequently complete a multispecialty
clinical diagnostic evaluation, MRI, psychometric testing, PET scan, genetic testing, and to
allow access to Medicare records will be assessed.
Interventions and Duration: The intervention is computerized cognitive speed of processing
training (SPT), which is also known as Useful Field of View (UFOV) training. SPT enhances
cognition through practice of adaptive exercises of perceptual processing. The goal of the
exercises is to increase the amount of information one can quickly process. SPT exercises are
designed to improve UFOV performance. A novel training exercise, recently shown to produce
larger UFOV gains (the proximal outcome of SPT), tonic and phasic alertness is also included.
Tonic and phasic alertness training improves attention, executive function and learning in
older adults. The exercise requires users to remain alert and engaged (tonic alertness) by
responding quickly to all target images and inhibiting response (phasic alertness) to random,
infrequent foils.
An active control condition of cognitive stimulation (i.e., computer games) is included. The
exercises are based upon correlational research that cognitively-stimulating leisure
activities can maintain cognition with increasing age. The control condition will be composed
of commercially available computer games (e.g., Sudoku, crossword puzzles) and is designed to
match SPT with the expectation-based influence on cognitive performance, intensity, and
overall engagement.
Participants will initially complete 25 sessions of training and will complete an additional
10 sessions of booster training 1- and 2- years later. Participants will first be instructed
to complete 2-3 sessions of training per week until 25 sessions are completed. At 1- year and
again at 2-years, participants will be instructed to complete an additional 10 sessions of
training.
Sample Size and Population: Adults 65 years of age and older (N=1600) will be randomly
assigned to SPT (n=800) or the control condition (n=800).
Inclusion Criteria:
- Be age 65 or older at time of consent
- Have ability to speak and understand English
- Report adequate sensorimotor capacity to perform the computer exercises
- Report adequate visual capacity to read from a computer screen at a typical viewing
distance
- Show adequate auditory capacity to understand conversational speech
- Show adequate motor capacity to touch a computer screen or control a computer mouse.
- Have no evidence of Mild Cognitive Impairment (MCI) or dementia, as assessed by the
Montreal Cognitive Assessment score >=26.
- Have adequate mental health (no self-reported diagnoses of mental illness that would
interfere with ability to comply with study procedures or benefit from intervention)
- Wiling to complete all study activities
- Ability to understand study procedures and comply with them for the length of the
study
Exclusion Criteria:
- Currently enrolled in another randomized clinical trial, treatment trial, or another
research study that assesses cognition
- Previous participation in a USF Cognitive Aging Lab cognitive training study
- Self-reported vision, hearing, or motor difficulties that would interfere with the
ability to complete the study interventions
- Self-reported diagnosis of mild cognitive impairment, dementia, stroke, traumatic
brain injury, brain tumor, or a neurological disorder that affects cognition or would
interfere with the ability to benefit from the study intervention (e.g., Parkinson
disease, multiple sclerosis), or any other unstable medical conditions that is
predisposing to imminent cognitive or functional decline (e.g., congestive heart
failure, chronic obstructive pulmonary disorder dependent on oxygen, or undergoing
chemotherapy or radiation).
- Self-reported use of medications typically prescribed for dementia such as Namenda,
Memantine, Namzaric, Donepezil, Aricept, Rivastigmine, Exelon, Razadyne, Galantamine,
or Reminyl.
- Completion of 10 or more hours of a computerized cognitive training program in the
last 5 years such as: Lumosity, Posit Science Brain Fitness, InSight, or Brain HQ,
Lace, CogMed, CogniFit, Happy Neuron, or Dakim
- Severe depressive symptoms (Geriatric Depression Scale score >=5)
We found this trial at
2
sites
4202 E Fowler Ave
Tampa, Florida 33620
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Jerri Edwards, PhD
Phone: 813-974-8572
University of South Florida The University of South Florida is a high-impact, global research university...
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Grand Rapids, Michigan 49503
Principal Investigator: Dave Morgan, PhD
Phone: 616-234-0952
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