Preventing Alzheimer's Disease With Cognitive Training (PACT)
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|ClinicalTrials.gov Identifier: NCT03848312|
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : December 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Age-related Cognitive Decline||Behavioral: Cognitive Training Behavioral: Computerized Cognitive Stimulation||Not Applicable|
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.
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Preventing Alzheimer's Disease With Cognitive Training: The PACT Trial|
|Actual Study Start Date :||February 19, 2019|
|Estimated Primary Completion Date :||March 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Computerized Cognitive Training
Participants will complete computerized cognitive training.
Behavioral: Cognitive Training
Participants will be completing a total of 45 computerized sessions.
Active Comparator: Computerized Cognitive Stimulation
Participants will complete cognitively-stimulating computer activities.
Behavioral: Computerized Cognitive Stimulation
Participants will be completing a total of 45 computerized cognitive stimulation sessions.
- Number of participants enrolled [ Time Frame: 1 year of data collection ]The primary outcome measure will be the number of participants enrolled in this pilot trial by one year after start of data collection. The goal is at least 1200 participants successfully enrolled after 1 year of data collection, demonstrating the feasibility of a larger trial.
- Adherence, which will be quantified as percent of participants who completed 20 or more sessions of assigned exercises. [ Time Frame: 1 year of data collection ]The percentage of participant's adherent to complete at least 20 sessions of assigned exercises. The goal is for at least 75% of those randomized to be adherent, demonstrating feasibility of a larger trial.
- Demographics of the sample including race, ethnicity, and education levels. [ Time Frame: 1 year of data collection ]This outcome is descriptive in nature. The diversity of the enrolled sample will be assessed by quantifying the racial, ethnic, and educational composition of the enrolled study sample. The goal is to approximate characteristics of the US older adult population by obtaining a sample that includes 85% Caucasians, 8.5% African Americans and 3.5% Asian Americans; across whom 7% will be of Hispanic ethnicity. The goal is for <=85% of the sample to have education levels of high school or more and >=15% of the sample with education levels less than high school.
- Proportion of enrolled participants who are willing to participate in a longitudinal trial [ Time Frame: 1 year of data collection ]The proportion of enrolled participants who are willing to further participate in a subsequent longitudinal trial will be quantified. This is assessed by one yes/no question. The proportion of participants who answer yes will be quantified. The goal is for at least 80% of the enrolled participants to indicate yes that they are willing to participate in a follow-up study.
- Percentage of participants who are willing to complete planned study measures. [ Time Frame: 1 year of data collection ]The willingness of participants to complete assessments in a subsequent trial including: clinical diagnostic evaluation, psychometric testing, MRI, PET scan, and genetic testing is assessed. Their willingness to allow access to medicare records will also be determined. This is assessed through a questionnaire with yes/no answers across six items. The percentage who endorse yes to these items will be measured. The goal is for at least 80% of the participants to endorse at least 4 of the questions as yes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848312
|Contact: Jerri Edwards, PhDfirstname.lastname@example.org|
|Contact: Alisa Houseknecht, PhDemail@example.com|
|United States, Florida|
|University of South Florida||Recruiting|
|Tampa, Florida, United States, 33620|
|Contact: Cognitive Aging Lab 813-974-8572 firstname.lastname@example.org|
|Principal Investigator: Jerri Edwards, PhD|
|Sub-Investigator: Ross Andel, PhD|
|Sub-Investigator: Ming Ji, PhD|
|Sub-Investigator: Jennifer Lister, PhD|
|Sub-Investigator: Elizabeth Hudak, PhD|
|Sub-Investigator: Jennifer O'Brien, PhD|
|United States, Michigan|
|Michigan State University||Recruiting|
|Grand Rapids, Michigan, United States, 49503|
|Contact: Baraa Abu-Dalu 616-234-0952 email@example.com|
|Contact: Kelsey Magolan 616-234-0952 firstname.lastname@example.org|
|Principal Investigator: Dave Morgan, PhD|