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.
Description
Preventing Alzheimer's Disease with Cognitive Training: The PACT Trial
The primary objective in the R56 phase was to establish the feasibility of the proposed field
trial including meeting participant enrollment goals. The feasibility of the field trial was
established by accruing 1000 enrolled participants. The secondary objective in the R56 phase
was 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 was also determined.
The trial is being expanded in the R01 phase with the goal of enrolling 7600 participants.
The primary goal is to ascertain the effectiveness of cognitive speed of processing training
(SPT) to reduce the incidence of Mild Cognitive Impairment (MCI) or dementia.
Design and Outcomes: A randomized clinical trial among 7600 adults 65 years of age and older
will be completed in order to test the effectiveness of computerized cognitive speed of
processing training (SPT) to reduce incidence of 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 one of two conditions of brain games and
will complete at least two 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 are asked to initially complete 25 sessions of training and will be asked
complete an additional 10 sessions of booster training 1- and 2- years later. Participants
are 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=7600) will be randomly
assigned to SPT (n=3800) or the active comparator condition (n=3800).
Details
Condition
Alzheimer's Disease, Age-related Cognitive Decline, Alzheimer's Disease and Related Dementias
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
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