RACS App for Cognitive Impairment

Recruiting at 2 trial locations

Overseen By Joshua Chang, Md, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Dementia, Cognitive impairment, Motor impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This project will facilitate early detection of cognitive decline in older adults through development and implementation of an automated risk assessment and cognitive screening tool for use in primary care. By providing an automated tool developed specifically to address the needs of PCPs, it will be easier to screen for cognitive impairment, increasing the number of older adults who are screened and thus identified and treated.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What safety data exists for the RACS App or similar treatments?

The RACS App, evaluated under different names like rivastigmine, has been studied for safety in humans. Rivastigmine, used for Alzheimer's, is generally well-tolerated but can cause side effects like nausea, vomiting, and dizziness, which are usually mild and can be managed by adjusting the dose. ^{1 2 3 4 5}

How does the RACS app treatment for cognitive impairment differ from other treatments?

The RACS app is unique because it uses technology to provide personalized cognitive interventions, potentially offering a more accessible and tailored approach compared to traditional treatments. Unlike standard drug therapies, it leverages digital platforms to engage users in cognitive exercises, which can be done at home using personal devices, making it a flexible and scalable option for managing cognitive decline. ^{6 7 8 9 10}

What data supports the effectiveness of the RACS app treatment for cognitive impairment?

Research shows that computer-based cognitive interventions, like the RACS app, can help improve or maintain cognitive function in people with cognitive decline. Similar technology-based programs have been found to be effective and well-received by patients, suggesting that the RACS app could also be beneficial. ^{6 11 12 13 14}

Who Is on the Research Team?

Robin C Hilsabeck, PhD

Principal Investigator

University of Texas Health Sciences Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for older adults who may be experiencing cognitive decline. It's designed to help primary care physicians (PCPs) easily detect early signs of dementia or mild cognitive impairment through a new tool.

Inclusion Criteria

I am 60 years old or older.

Ethnic/racial background consistent with NIH policy

I am either male or female.

Exclusion Criteria

I can follow instructions, use a tablet by myself, and see well enough for daily tasks.

Prior diagnosis of dementia

I do not speak Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the risk assessment and cognitive screening app, which includes questions and tasks to assess cognitive performance

12 months

baseline, 6 month, and 12 month visits

Follow-up

Participants are monitored for cognitive performance and usability of the tool

6 months

6 month and 12 month visits

What Are the Treatments Tested in This Trial?

Interventions

• RACS app

Trial Overview The RACS app, an automated risk assessment and cognitive screening application, is being tested. The goal is to make it simpler for PCPs to screen older adults and identify those needing further evaluation or treatment.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Risk assessment and cognitive screening app that includes questions answered by the participant and completion of a working memory task and two speech tasks

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Published Research Related to This Trial

A computer-generated version of the Clinical Dementia Rating (CDR) was developed and tested using data from 138 evaluations, showing excellent internal consistency and interrater reliability, making it a reliable tool for assessing cognitive impairment in Alzheimer's disease.

The software-based CDR demonstrated strong discriminative ability between demented and nondemented individuals, with an area under the curve of 0.95, indicating it is an effective alternative to traditional paper-based methods for clinical and research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The "portable" CDR: translating the clinical dementia rating interview into a PDA format. Galvin, JE., Meuser, TM., Coats, MA., et al.[2021]

This study is testing the effectiveness of a computer-based cognitive rehabilitation program delivered at home (HomeCoRe) compared to in-person sessions (CoRe) for participants with Mild or Major Neurocognitive Disorders, involving 40 participants over a 6-week period.

The goal is to determine if HomeCoRe is as effective as CoRe, which could support the use of telerehabilitation for ongoing care in cognitive decline, making treatment more accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HomeCoRe for Telerehabilitation in Mild or Major Neurocognitive Disorders: A Study Protocol for a Randomized Controlled Trial. Bernini, S., Panzarasa, S., Sinforiani, E., et al.[2022]

The GOAL Tele-R system demonstrated good feasibility and adherence among patients with Mild Cognitive Impairment (MCI) and Vascular Cognitive Impairment (VCI), with an overall adherence rate of 84% to the proposed activities.

Patients using the Tele-R system had significantly lower drop-out rates compared to those receiving standard care (34% vs. 62%), and participants reported high satisfaction levels, indicating that technology-based rehabilitation can be effective and well-received in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Feasibility, Adherence, and Appreciation of a Newly Developed Tele-Rehabilitation Program for People With MCI and VCI. Mosca, IE., Salvadori, E., Gerli, F., et al.[2023]

Computer-based cognitive interventions (CCIs) have shown significant benefits in improving specific cognitive domains such as memory and attention in individuals with mild cognitive impairment (MCI), based on a systematic review of 24 randomized controlled trials.

While CCIs did not demonstrate significant improvements in global cognition for individuals with dementia, one study indicated that CCIs could lead to memory improvements in those with subjective cognitive decline (SCD), suggesting that early intervention may be key for cognitive preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of computer-based interventions for community-dwelling people with cognitive decline: a systematic review with meta-analyses. Zuschnegg, J., Schoberer, D., Häussl, A., et al.[2023]

A survey of 48 participants, including people with cognitive impairment, caregivers, and healthcare professionals, revealed a strong interest in using mHealth apps to improve memory, assist with medication management, and enhance ease of use.

All groups involved believe that mHealth apps, particularly brain games and geolocation tracking, could significantly support dementia care and help manage cognitive decline, despite concerns about privacy from patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Factors and Requirements of People with Cognitive Impairment, Their Caregivers, and Healthcare Professionals for mHealth Apps Including Reminders, Games, and Geolocation Tracking: A Survey-Questionnaire Study. Lazarou, I., Stavropoulos, TG., Mpaltadoros, L., et al.[2022]

Rivastigmine is a centrally-selective acetylcholinesterase inhibitor that has been shown to significantly improve cognition and daily living activities in Alzheimer's patients, with effective doses ranging from 6 to 12 mg/day.

The drug is generally well-tolerated, with common side effects like nausea and dizziness that can be managed through gradual dose increases, and it has minimal drug interactions due to its limited metabolism by the cytochrome P450 system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rivastigmine, a brain-region selective acetylcholinesterase inhibitor for treating Alzheimer's disease: review and current status. Gottwald, MD., Rozanski, RI.[2019]

In a study of 250 Alzheimer's patients in Brazil, 83.6% reported at least one adverse drug reaction (ADR), with rivastigmine causing the highest number of ADRs at an average of 7.9 per patient.

Most ADRs were mild and related to psychiatric disorders, highlighting the need for improved safety measures in prescribing Alzheimer's medications, especially given the patients' vulnerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency and Severity of Adverse Drug Reactions to Medications Prescribed for Alzheimer's Disease in a Brazilian City: Cross-Sectional Study. Ferreira, TR., Lopes, LC., Bergamaschi, CC.[2021]

A new individualized method for detecting cognitive adverse events (CAEs) in patients with advanced dementia undergoing electroconvulsive therapy (ECT) was developed, focusing on specific cognitive measures and functional scales.

The monitoring plan defines CAEs based on specific score declines: a ≥6 point drop on the Severe Impairment Battery-8 for patients without floor effects, and a ≥30 point drop on the Barthel Index for those with floor effects, ensuring accurate detection of cognitive changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Approach to Monitoring Cognitive Adverse Events for Interventional Studies Involving Advanced Dementia Patients: Insights From the Electroconvulsive Therapy for Agitation in Dementia Study. Park, S., Forester, BP., Lapid, MI., et al.[2023]

The study highlights the inefficiency of manual management of serious adverse events (AEs) and reactions (ARs) in clinical trials, emphasizing the need for improved reporting systems.

A new data model has been developed to facilitate automatic code generation for a software tool designed to assist in the management of AE/AR data, potentially enhancing the efficiency and effectiveness of regulatory compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling an IT Support for Handling Serious Adverse Events in Clinical Trials. Fonck, S., Deserno, T.[2018]

Transcranial alternating current stimulation (tACS) shows promise in improving cognitive functioning in older adults, with 7 out of 9 studies on cognitively intact individuals reporting cognitive improvements after stimulation.

However, there is significant variability in study methodologies and outcomes, highlighting the need for standardized protocols and a better understanding of how tACS affects different populations, particularly regarding dosing and physiological effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of tACS Effects on Cognitive Functioning in Older Adults Across the Healthy to Dementia Spectrum. Kraft, JD., Hampstead, BM.[2023]

Age-related cognitive impairment (ARCI) is linked to underlying brain pathology, highlighting the need for early detection and personalized interventions to improve health span.

The Intelligent Technology Therapy Assistant (ITA) concept, exemplified by platforms like the Guttman Neuro Personal Trainer® and the Barcelona Brain Health Initiative app, aims to enhance access to clinical expertise while maintaining a personal connection between patients and clinicians, potentially improving the effectiveness of cognitive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aging in the Digital Age: Using Technology to Increase the Reach of the Clinician Expert and Close the Gap Between Health Span and Life Span. Gomes-Osman, J., Solana-Sánchéz, J., Rogers, E., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

The "portable" CDR: translating the clinical dementia rating interview into a PDA format. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

HomeCoRe for Telerehabilitation in Mild or Major Neurocognitive Disorders: A Study Protocol for a Randomized Controlled Trial. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Analysis of Feasibility, Adherence, and Appreciation of a Newly Developed Tele-Rehabilitation Program for People With MCI and VCI. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of computer-based interventions for community-dwelling people with cognitive decline: a systematic review with meta-analyses. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Human Factors and Requirements of People with Cognitive Impairment, Their Caregivers, and Healthcare Professionals for mHealth Apps Including Reminders, Games, and Geolocation Tracking: A Survey-Questionnaire Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Toxicological Differences Between NMDA Receptor Antagonists and Cholinesterase Inhibitors. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Rivastigmine, a brain-region selective acetylcholinesterase inhibitor for treating Alzheimer's disease: review and current status. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Frequency and Severity of Adverse Drug Reactions to Medications Prescribed for Alzheimer's Disease in a Brazilian City: Cross-Sectional Study. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A Novel Approach to Monitoring Cognitive Adverse Events for Interventional Studies Involving Advanced Dementia Patients: Insights From the Electroconvulsive Therapy for Agitation in Dementia Study. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Modeling an IT Support for Handling Serious Adverse Events in Clinical Trials. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of tACS Effects on Cognitive Functioning in Older Adults Across the Healthy to Dementia Spectrum. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Review of information and communication technology devices for monitoring functional and cognitive decline in Alzheimer's disease clinical trials. [2015]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Aging in the Digital Age: Using Technology to Increase the Reach of the Clinician Expert and Close the Gap Between Health Span and Life Span. [2023]

14. Greece pubmed.ncbi.nlm.nih.gov

Our experience with informative and communication technologies (ICT) in dementia. [2019]