What side effects are associated with this type of intervention?

Neuroplasticity-based computerized training programs, such as the PACR-CT, are generally considered to be low-risk interventions with minimal side effects. Participants may experience temporary frustration or fatigue due to the cognitive demands of the training exercises. In contrast, pharmacological treatments for age-related cognitive decline, such as cholinesterase inhibitors, can have side effects including gastrointestinal issues, muscle cramps, and insomnia. It is important for patients to discuss potential side effects with their healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for age-related cognitive decline, primarily focusing on Alzheimer's disease, such as donepezil, rivastigmine, and memantine. However, non-pharmacological interventions like neuroplasticity-based computerized training programs, similar to the PACR-CT being studied, have not been widely approved by the FDA. These programs aim to enhance cognitive function through targeted brain exercises and have shown promise in clinical trials, but they are still under investigation for long-term efficacy and regulatory approval.

What other types of research exist?

Promising, novel alternatives to PACR-CT for age-related cognitive decline in 2024 include: 1) Digital therapeutics like Akili Interactive's EndeavorRx, which uses video game-based interventions to improve cognitive function. 2) Virtual reality (VR) cognitive training programs that provide immersive environments for cognitive exercises. 3) Transcranial direct current stimulation (tDCS) combined with cognitive training to enhance neuroplasticity. 4) Advanced neurofeedback techniques that allow patients to train their brain activity in real-time. 5) Multi-domain lifestyle interventions incorporating physical exercise, diet, and cognitive training, such as the FINGER study protocol.

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Behavioural Intervention

Brain Enhancement Training for Age-Related Cognitive Decline (BETTER Aging Trial)

N/A

Recruiting

Led By Hyun Kyu Lee, PhD

Research Sponsored by Posit Science Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 5 years and at 3 months

Awards & highlights

BETTER Aging Trial Summary

This trial tests the long-term benefits of a computer-based training program. It is Non-Significant Risk and involves 10 weeks of initial training plus a booster.

Who is the study for?

This trial is for people aged 70 or older who speak English fluently, can see and hear well enough to use a computer, and can control a mouse. They must not have dementia as shown by the MoCA test. Those with severe visual/hearing deficits, recent cognitive training, suicidal thoughts, certain medical conditions or implants that interfere with MRI cannot join.Check my eligibility

What is being tested?

The study tests a web-based brain training program (PACR-CT) on elders to see if it helps their cognition five years after initial training and examines the effects of an additional 10 weeks of booster training. The software poses no significant risk.See study design

What are the potential side effects?

Since this intervention involves non-invasive computerized cognitive exercises designed for elderly individuals, there are minimal expected side effects; however, some participants may experience eye strain or mild frustration.

BETTER Aging Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 5 years and at 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 5 years and at 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 5 years and at 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in performance on global cognitive composite score

Secondary outcome measures

Blood-based Biomarker for Alzheimer's Disease

Change in Depressive Symptoms

Change in brain function

+7 more

Other outcome measures

Change in Diet

Change in Functional Abilities

Change in Life Satisfaction

+5 more

BETTER Aging Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental TreatmentExperimental Treatment1 Intervention

Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Neuroplasticity-based computerized training programs, such as the PACR-CT, aim to enhance cognitive function by leveraging the brain's ability to reorganize and form new neural connections. These programs typically involve targeted cognitive exercises designed to stimulate specific brain regions, thereby improving memory, attention, and problem-solving skills. This approach is crucial for patients with Age-related Cognitive Decline as it directly addresses the underlying neural deterioration by promoting brain health and cognitive resilience, potentially slowing the progression of cognitive impairments and improving quality of life.

Committee on High-quality Alzheimer's Disease Studies (CHADS) consensus report.Observations and suggestions on antidementia drug development.

Find a Location

Who is running the clinical trial?

University of IowaOTHER

454 Previous Clinical Trials

881,858 Total Patients Enrolled

2 Trials studying Age-related Cognitive Decline

230 Patients Enrolled for Age-related Cognitive Decline

Posit Science CorporationLead Sponsor

38 Previous Clinical Trials

4,021 Total Patients Enrolled

2 Trials studying Age-related Cognitive Decline

230 Patients Enrolled for Age-related Cognitive Decline

The University of Texas at DallasOTHER

60 Previous Clinical Trials

106,399 Total Patients Enrolled

2 Trials studying Age-related Cognitive Decline

205 Patients Enrolled for Age-related Cognitive Decline

Media Library

PACR-CT (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05599490 — N/A

Age-related Cognitive Decline Research Study Groups: Experimental Treatment

Age-related Cognitive Decline Clinical Trial 2023: PACR-CT Highlights & Side Effects. Trial Name: NCT05599490 — N/A

PACR-CT (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05599490 — N/A

~120 spots leftby Apr 2026

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