Brain Enhancement Training Towards Elders Resilience to Aging, Phase IIB

Age-related Cognitive Decline Clinical Trial

— BETTER Aging  

Official title:

BETTER Aging Trial: Brain Enhancement Training Towards Elders Resilience to Aging, Phase IIB

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599490
• Other study ID #: PSC-1024-22
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: February 2024
• Source: Posit Science Corporation
• Contact: Sarah-Jane Grant, MA
• Phone: 415-539-3130
• Email: sarah-jane.grant[@]positscience.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to examine the longer-term benefits of a novel, neuroplasticity-based, computerized and web-deliverable training program (PACR-CT) five years from the initial 10 weeks of training from our Phase II study - Protocol #: PSC-0605-17 (Aim 1) and test the interactive effect of previous training and 10 weeks of booster training (Aim 2). Both the study and the software being investigated meet the criteria of Non-Significant Risk.

Description:

This study will employ a single arm, open label design with use of the PACR-CT with all participants who completed the Phase II study, as well as approximately 60 new participants (with a goal of 40 completers) who are age-matched and untrained older adults. After consent, only the new, untrained participants will complete the screening visit. Then all participants will perform the pre-training visit (cognitive and functional assessments, MRI/fMRI and blood draw), followed by 10 weeks of training, and then followed by post-training visit (cognitive and functional assessments and MRI/fMRI).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Participant must be 70 years of age or older

• Participant must be a fluent English speaker

• Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse

• Participant must not have evidence of dementia as indicated by the Montreal Cognitive Assessment (MoCA)

Exclusion Criteria:

• Participant with any medical illnesses, injuries or conditions predisposing to imminent functional and/or cognitive decline

• Participant requiring caregiver assistance in dressing/personal hygiene

• Participant with severe visual deficits (including visual neglect, partial field cuts, anopias) and/or severe hearing deficit that would prevent use of the computerized treatment program

• Participant with recent participation of computer-delivered cognitive training within 2 years of consent

• Participant with claustrophobia or any other contraindication to MRI scanning

• Participant with inability to complete a 1-hour MRI

• Pregnant women

• Participant with any implanted devices above the waist (e.g., cardiac pacemaker or auto-defibrillators, neural pacemaker, aneurysm clips, cochlear implant, metallic bodies in the eye or central nervous system, any form of wires or metal devices that may concentrate radio frequency fields)

• Participants with active suicidal ideation with specific plan and intent or suicide-related behaviors within 2 months of consent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)

Related Conditions & MeSH terms

• Age-related Cognitive Decline
• Cognitive Dysfunction

Intervention

Other:
• Computerized Plasticity-Based Adaptive Cognitive Training
Forty-two minutes of training on computerized exercises that targets processing speed, memory and attention.

Locations

Country	Name	City	State
United States	University of Texas at Dallas	Dallas	Texas
United States	University of Iowa	Iowa City	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
Posit Science Corporation	The University of Texas at Dallas, University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Stress	Between-group magnitude of change in sum score using the self-report measure, Perceived Stress Scale (PSS-10). The scoring range is 0-40. Higher scores indicate higher perceived stress.	At 5 years and at 3 months
Other	Change in Self-Efficacy	Between-group magnitude of change in sum score using the self-report measure, Self-Efficacy Survey. The scoring range is 10-40. Lower scores indicate lower self efficacy.	At 5 years and at 3 months
Other	Change in Life Satisfaction	Between-group magnitude of change in sum score using the self-report measure, Life Satisfaction Scale. The scoring range is 5-35. Lower scores indicate lower life satisfaction.	At 5 years and at 3 months
Other	Change in Physical Activity	Change in total score based on weekly self-report dairy about physical activity during training period.	At 5 years and at 3 months
Other	Change in Diet	Change in total score based on weekly self-report dairy about diet during training period.	At 5 years and at 3 months
Other	Change in Social Activity	Change in total score based on weekly self-report dairy about social activity during training period.	At 5 years and at 3 months
Other	Change in Sleep	Change in total score based on weekly self-report dairy about sleep during training period.	At 5 years and at 3 months
Other	Change in Functional Abilities	Change in total score based on weekly self-report dairy about functional abilities during training period.	At 5 years and at 3 months
Primary	Change in performance on global cognitive composite score	Change in performance on global cognitive composite score based on the average of all normalized assessment measures.	At 5 years and at 3 months
Secondary	Change in performance on processing speed composite score	Change in performance on processing speed will be measured using the composite score created by averaging the z-scores of Pattern Comparison, Letter Comparison, and Digit Symbol Coding tasks.	At 5 years and at 3 months
Secondary	Change in performance on working memory	Change in performance on working memory will be measured using the composite score created by averaging the z-scores of Visual Short Term Memory and N-Back Tasks.	At 5 years and at 3 months
Secondary	Changes in performance on episodic memory	Change in performance on episodic memory will be measured using the composite score created by averaging the z-scores of Selective Reminding Task and Face Name Task.	At 5 years and at 3 months
Secondary	Change in performance on executive function	Change in performance on executive function will be measured using the composite score created by averaging the z-scores of Flanker Task and Task Switch (fMRI task).	At 5 years and at 3 months
Secondary	Change in brain function	Change in resting state functional connectivity will be measured by resting State T2*weighted EPI-BOLD, a 10-minute task-free BOLD contrast sequence consisting of 300 volumes (TR=2000 ms/TE=30ms) at 3.4mm3 in-plane resolution and 3mm slice thickness. Participants will be instructed to keep their eyes open and maintain attention on a central gray fixation cross on a black screen.	At 5 years and at 3 months
Secondary	Change in brain structure	3D T1-Weighted multi-echo MPRAGE. Morphometric analyses will be based on this MRI sequence (not accelerated because the reliability of acceleration for multi-site studies has not yet been established). We will achieve spatial resolution of 1 x 1 x 1 mm voxels.	At 5 years and at 3 months
Secondary	Change in task-related brain activation	Change in functional connectivity and brain activation will be measured while performing Task Switch.	At 5 years and at 3 months
Secondary	Change in functional performance	Between-group magnitude of change in sum time of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance.	At 5 years and at 3 months
Secondary	Change in Depressive Symptoms	Between-group magnitude of change in sum score using the self-report measure, Center for Epidemiologic Studies Depression Scale (CES-D). The scoring range is 0-60. Higher scores indicate the presence of more symptomatology.	At 5 years and at 3 months
Secondary	Blood-based Biomarker for Alzheimer's Disease	Group differences in the P-tau181, Aß1-42/Aß1-40 concentrations	At 5 years