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Cognitive DeclineNCT04848935

CURATE.AI COR-Tx Trial for Post Brain Radiotherapy Patients

A study testing CURATE.AI in people with Cognitive Decline, run by National University Hospital, Singapore at 2 sites in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Cognitive deficit is common in patients who have undergone whole brain or partial brain radiotherapy. To counteract intellectual deterioration, the conventional strategies includes drug- based treatments such as donezepil and memantine, which have shown to only provide marginal improvement and, cognitive training… Read more about this study

Who is it for?
Ages 21 to 99 years
Conditions the study is for
Cognitive Decline
What is being tested?
CURATE.AI
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesSingapore
Study dates
14 Jun 2021to 1 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >21 years.
  • ECOG performance status 0 to 2.
  • Patients with a neoplastic condition (benign or malignant) involving the brain or skull requiring radiotherapy (with or without chemotherapy).
  • Patients with a life expectancy of at least 6 months.

Who cannot join

  • Pregnant or breastfeeding women.
  • Patients undergoing stereotactic radiosurgery (single fraction).
  • Patients who are undergoing re-irradiation to the same area of the brain.
  • Patients physically incapable of using computer tablet (either due to vision loss or dominant hand weakness)
  • Patients who cannot understand spoken English language.
  • Patients who are unable to give informed consent.

Trial locations and contacts

2 sites in 1 country.

Dr Balamurugan A Vellayappan contact

+65 67795555

bala_vellayappan@nuhs.edu.sg

Qian Yee, Queenie Chai contact

queenie_qy_chai@nuhs.edu.sg

Singapore2 sites, 2 recruiting

  • National University Hospital

    Singapore

    Qian Yee, Queenie Chai, Coordinator, queenie_qy_chai@nuhs.edu.sg

    Fatin Aliyah, Coordinator, fatin_hussin@nuhs.edu.sg

    Recruiting

  • The N.1 Institute for Health (N.1), NUS

    Singapore

    Xavier Tadeo, PhD, biextc@nus.edu.sg

    Yoong Hun Ong, MSc, +6596680807, yh.ong@nus.edu.sg

    Recruiting

Other trials in Singapore

About this study

Official title: CURATE.AI Optimised Digital COgnitive Rehabilitation Therapy (COR-Tx) for Post Brain Radiotherapy Patients: CURATE.AI COR-Tx Mixed-methods Feasibility Clinical Trial

Cognitive deficit is common in patients who have undergone whole brain or partial brain radiotherapy. To counteract intellectual deterioration, the conventional strategies includes drug- based treatments such as donezepil and memantine, which have shown to only provide marginal improvement and, cognitive training regimens, both of which are usually administered at fixed dose/intensities often leading to sub-optimal responses. This study aims to address this clinically relevant problem by harnessing the CURATE.AI platform to identify N-of-1cognitive training profiles the can enhance learning trajectories through individualised calibration and training regimens. CURATE.AI is a phenotypic personalised medicine (PPM) platform that correlates a patient's phenotypic response (cognitive performance) to a certain input (training intensity) based exclusively on the patient's data. This PPM platform is independent of biological system or interventional agent and can be applied to any disorder treatment where dosing/intensity could be better personalised. CURATE.AI is expected to optimise/personalise cognitive training in post-brain radiotherapy patients by dynamically modulating the intensity of a digital cognitive test battery that measures executive processing, multitasking and perceptual learning tasks. In addition, this clinical feasibility trial aims to assess this cognitive test battery as a potential analogous or complementary diagnostic tool as compared to traditional cognitive evaluations performed by a clinician.

Read the detailed description

Brain radiotherapy causes downstream cognitive deficits. Drug-based cognitive decline treatments show little improvement and side effects may reduce patient compliance. Regimens are usually administered at a fixed dose that doesn't incorporate high patient variability, leading to sub-optimal responses.

Effective cognitive training can improve cognitive performance. Artificial intelligence platforms show great potential for training personalisation. The CURATE.AI platform can be used to identify N-of-1 (single subject) training profiles that can be used to optimise learning trajectories through individualised calibration and training regimens, potentially leading to improved outcomes compared to standard static or adaptive training strategies. CURATE.AI uses only a subject's own performance data to identify the intensity needed for his/her best output. As the subject evolves during the course of intervention, the training intensities are dynamically modulated to maintain performance within a given range.

Here the investigators propose to test the feasibility of CURATE.AI, with a digital cognitive test battery as the interface, as an adaptive training platform for cognitive training addressed to improve brain cancer radiotherapy patients' cognitive performance. The acceptability, implementation and limited efficacy of the digital intervention (DI) will be explored. In addition, the investigators propose to test the feasibility of the digital cognitive test battery potential as a digital diagnostic (DD) tool as compared to traditional cognitive evaluations performed by a clinician. User experience and usability will also be explored.

Being tested
CURATE.AI
Keywords
Oncology, Digital therapeutics, Cognitive evaluation, Digital diagnostic, Cognitive training, Phenotypic Personalised Medicine (PPM), Multi-Attribute Task Battery (MATB), Training intensity, Radiotherapy, CURATE.AI
Medical subject headings
Cognitive Dysfunction, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CURATE.AIDevice

    CURATE.AI will be utilised to provide personalised training intensity recommendations (low, medium or high) to the patients during the digital cognitive test battery DI session. The difficulty of each task will be modulated by CURATE.AI by adjusting the frequency of critical events that demand evaluation and/or response.

Study groups in NCT04848935
Study groupRoleWhat they receive
CURATE.AIExperimentalA cognitive evaluation and a Digital Diagnostic (DD) session performed anytime before radiotherapy will serve as the baseline. After the radiotherapy treatment, which can last between 1 to 6.5 weeks, patients will have a variable recovery time (0 to 4 weeks). Subsequently, patients will be subject to a cognitive evaluation and a DD session, right before starting the Digital Intervention (DI) training. This training will comprise ten weeks of DI (three 10-15 minute sessions per week). Patients will complete cognitive evaluations and DD sessions at the end of DI, and 16 and 32 weeks after the end of DI.
Receives: Device: CURATE.AI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient acceptability of the digital cognitive test battery DI/DD obtained during a semi-structured interview

    Qualitative summary of patient acceptability of the digital cognitive test battery DI/DD

    Measured: One visit 60 minutes (at the end of the 10 week intervention)

  2. Patient adherence to the DI/DD

    Percentage of completed DI/DD sessions

    Measured: up to 12 months

  3. Patient attrition rate to the DI/DD

    Percentage of patients that drop out of DI/DD

    Measured: up to 12 months

  4. Percentage of CURATE.AI profiles successfully created and applied

    Measured: up to 12 months

  5. Timely delivery of DI/DD at indicated time points

    Percentage of DI/DD sessions successfully delivered by study team at indicated time points

    Measured: up to 12 months

  6. Digital intervention limited efficacy

    Change in cognitive performance as measured by the standard of care cognitive evaluations pre-post digital intervention

    Measured: up to 12 months

  7. Digital diagnostic limited efficacy

    Correlation between standard of care cognitive evaluations scores and digital diagnostic scores

    Measured: up to 12 months

Secondary outcomes (1)

  1. 1. Usability of the digital cognitive test battery DI/DD obtained during a semi-structured interview

    Qualitative summary of patient usability of the digital cognitive test battery DI/DD

    Measured: One visit 60 minutes (at the end of the 10 week intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2021
  2. Study start14 Jun 2021
  3. Primary completion1 Jan 2022 (estimated)
  4. Study completion1 Jul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04848935
Sponsor's protocol ID
2020/00249
Status last verified
Nov 2021
First submitted
2 Mar 2021
Last updated
12 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kee, Theodore & Weiyan, Chee & Blasiak, Agata & Chong, Jordan & Chen, Jonna & Yeo, B.T. Thomas & Ho, Dean & Asplund, Christopher. (2019). Harnessing CURATE.AI as a Digital Therapeutics Platform by Identifying N-of-1 Learning Trajectory Profiles. Advanced Therapeutics. 2. 1900023. 10.1002/adtp.201900023.

  • Zarrinpar A, Lee DK, Silva A, Datta N, Kee T, Eriksen C, Weigle K, Agopian V, Kaldas F, Farmer D, Wang SE, Busuttil R, Ho CM, Ho D. Individualizing liver transplant immunosuppression using a phenotypic personalized medicine platform. Sci Transl Med. 2016 Apr 6;8(333):333ra49. doi: 10.1126/scitranslmed.aac5954.

    PubMed 27053773

  • Pantuck AJ, Lee DK, Kee T, Wang P, Lakhotia S, Silverman MH, Mathis C, Drakaki A, Belldegrun AS, Ho CM, Ho D. Modulating BET bromodomain inhibitor ZEN-3694 and enzalutamide combination dosing in a metastatic prostate cancer patient using CURATE. AI, an artificial intelligence platform. Advanced Therapeutics. 2018 Oct;1(6):1800104.

  • Remus A, Tadeo X, Kai GNS, Blasiak A, Kee T, Vijayakumar S, Nguyen L, Raczkowska MN, Chai QY, Aliyah F, Rusalovski Y, Teo K, Yeo TT, Wong ALA, Chia D, Asplund CL, Ho D, Vellayappan BA. CURATE.AI COR-Tx platform as a digital therapy and digital diagnostic for cognitive function in patients with brain tumour postradiotherapy treatment: protocol for a prospective mixed-methods feasibility clinical trial. BMJ Open. 2023 Oct 24;13(10):e077219. doi: 10.1136/bmjopen-2023-077219.

    PubMed 37879700

Questions about this trial

What is this clinical trial studying?

A study testing CURATE.AI in people with Cognitive Decline, run by National University Hospital, Singapore at 2 sites in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dr Balamurugan A Vellayappan (+65 67795555, bala_vellayappan@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient acceptability of the digital cognitive test battery DI/DD obtained during a semi-structured interview (time frame: One visit 60 minutes (at the end of the 10 week intervention)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04848935, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2021.

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