What side effects are associated with this type of intervention?

Common treatments aimed at enhancing executive functioning and cognitive abilities in older adults, such as cognitive training programs, generally have minimal physical side effects. However, participants may experience mental fatigue, frustration, or stress due to the cognitive demands of the training. Additionally, the effectiveness of these interventions can vary, and some individuals may not experience significant improvements. It is important to monitor for any signs of increased anxiety or depressive symptoms, as these can occasionally be exacerbated by the challenges of cognitive training.

What prior FDA approvals exist?

There are no specific FDA-approved drugs solely for enhancing executive functioning to improve global cognitive ability and reduce cognitive impairment in aging. However, some treatments for cognitive decline in conditions like Alzheimer's disease, such as cholinesterase inhibitors (donepezil, galantamine) and memantine, have shown benefits in cognitive function. These treatments are somewhat related to the goals of the Executive Functioning Training study, which aims to improve cognitive abilities through targeted training programs.

What other types of research exist?

Promising novel alternatives to Executive Functioning Training for aging patients include: 1) Cognitive Behavioral Therapy (CBT) for insomnia, which has shown improvements in cognitive function and psychological well-being; 2) Tai Chi and Qigong, which have demonstrated benefits in motor and non-motor functions, including cognitive abilities; 3) Multidisciplinary rehabilitation programs that combine physical, cognitive, and emotional therapies; 4) Mindfulness-based interventions, such as Mindfulness-Based Stress Reduction (MBSR), which have been effective in improving mood and cognitive function; and 5) Digital cognitive training programs that offer targeted exercises to enhance specific cognitive domains.

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Executive Functioning Training for Cognitive Impairment in Aging Adults with HIV (EFT Trial)

Phase 2

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

EFT Trial Summary

This trial will study how cognitive training can reduce HIV-Associated Neurocognitive Disorder (HAND) in older people with HIV, improving functioning & quality of life. It will also identify how to target executive functioning to improve global cognitive ability & reduce cognitive IIV.

Who is the study for?

This trial is for English-speaking adults over 40 with HIV-Associated Neurocognitive Disorder (HAND) who can meet in person and commit to a ~12-week program. It's not for those with major health issues like schizophrenia, significant brain trauma, or recent COVID-19 infection; those undergoing intense treatments like chemo; or individuals living far from the center or in unstable housing.Check my eligibility

What is being tested?

The study tests if Executive Functioning Training over 20 hours improves cognitive abilities in aging adults with HAND compared to no training. Participants are split into two groups: one receives the training and the other doesn't, allowing researchers to see if there's an improvement in cognitive functioning.See study design

What are the potential side effects?

Since this is a non-medical intervention focusing on cognitive training, traditional physical side effects associated with medications are not expected. However, participants may experience fatigue or mental strain due to the intensity of the exercises.

EFT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Adherence Rates (after study data collection)

Attrition Rates (after study data collection)

Baseline Assessment of Cognitive Training

+2 more

Secondary outcome measures

BRACE+ (BrainBaseline Assessment of Cognition and Everyday Functioning)

EFT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Executive Functioning TrainingExperimental Treatment1 Intervention

BrainHQ (POSIT Science Inc.) computerized cognitive training modules will be used as in our other studies; but these will focus on executive functioning training. These programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises.

Group II: No-Contact Control GroupActive Control1 Intervention

These participants will not receive any intervention.

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

Common treatments for aging, such as cognitive training programs, work by enhancing executive functioning, which involves the higher-level allocation of cognitive resources. These programs aim to improve global cognitive ability and reduce cognitive impairment. This is particularly important for aging patients as it can help mitigate the severity and prevalence of cognitive disorders, such as dementia, thereby improving their quality of life and daily functioning.

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Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,594 Previous Clinical Trials

2,282,355 Total Patients Enrolled

16 Trials studying Aging

1,427 Patients Enrolled for Aging

Media Library

Executive Functioning Training Clinical Trial Eligibility Overview. Trial Name: NCT05598047 — Phase 2

Aging Research Study Groups: Executive Functioning Training, No-Contact Control Group

Aging Clinical Trial 2023: Executive Functioning Training Highlights & Side Effects. Trial Name: NCT05598047 — Phase 2

Executive Functioning Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05598047 — Phase 2

~40 spots leftby Dec 2024

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