Preventing Alzheimer's With Cognitive Training (PACT)
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|ClinicalTrials.gov Identifier: NCT03848312|
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : November 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Age-related Cognitive Decline Alzheimer's Disease and Related Dementias||Behavioral: Cognitive Training Behavioral: Computerized Cognitive Stimulation||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Cognitive Training to Reduce Incidence of Cognitive Impairment in Older Adults|
|Actual Study Start Date :||February 19, 2019|
|Estimated Primary Completion Date :||January 31, 2026|
|Estimated Study Completion Date :||January 31, 2026|
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.
- Incidence of mild cognitive impairment or dementia [ Time Frame: Three years ]clinical diagnosis of mild cognitive impairment or dementia
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, PhDemail@example.com|
|Contact: Elizabeth Hudak, PhDfirstname.lastname@example.org|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32611|
|Contact: Andrew O'Shea 352-294-8314 PACTUF@phhp.ufl.edu|
|Principal Investigator: Adam J Woods, PhD|
|University of North Florida||Recruiting|
|Jacksonville, Florida, United States, 32224|
|Contact: Heather Burk 904-620-4263 PACTJax@unf.edu|
|Principal Investigator: Jody Nicholson, PhD|
|University of South Florida||Recruiting|
|Tampa, Florida, United States, 33620|
|Contact: Cognitive Aging Lab 813-974-8572 email@example.com|
|Principal Investigator: Jerri Edwards, PhD|
|Sub-Investigator: Jennifer Lister, PhD|
|Sub-Investigator: Elizabeth Hudak, PhD|
|Sub-Investigator: Jennifer O'Brien, PhD|
|Sub-Investigator: Amanda Smith, MD|
|Principal Investigator: Aryn Harrison-Bush, PhD|
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|
|Contact: Marianne Chanti-Ketterl, PhD 919-668-3154 PACTStudy@duke.edu|
|Principal Investigator: Brenda Plassman, PhD|
|United States, South Carolina|
|Clemson University Institute for Engaged Aging||Recruiting|
|Seneca, South Carolina, United States, 29672|
|Contact: Christine B Phillips, PhD 864-916-6220 PACT@clemson.edu|
|Contact: Kimberly Scoles 864-916-6220 PACT@clemson.edu|
|Principal Investigator: Lesley A Ross, PhD|