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

NCT04848935 | Unknown

• 1 other identifier: 2020/00249
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Cognitive Decline

Keywords

Oncology; Digital therapeutics; Cognitive evaluation; Digital diagnostic; Cognitive training; Phenotypic Personalised Medicine (PPM); Multi-Attribute Task Battery (MATB); Training intensity; Radiotherapy; CURATE.AI

Outcome Measures

Primary Outcomes (7)

• 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

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

• Patient adherence to the DI/DD

  Percentage of completed DI/DD sessions

  up to 12 months

• Patient attrition rate to the DI/DD

  Percentage of patients that drop out of DI/DD

  up to 12 months

• Percentage of CURATE.AI profiles successfully created and applied

  up to 12 months

• Timely delivery of DI/DD at indicated time points

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

  up to 12 months

• Digital intervention limited efficacy

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

  up to 12 months

• Digital diagnostic limited efficacy

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

  up to 12 months

Secondary Outcomes (1)

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

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

Study Arms (1)

CURATE.AI

EXPERIMENTAL

A 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.

Device: CURATE.AI

Interventions

CURATE.AI DEVICE

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.

CURATE.AI

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator
• The N.1 Institute for Health (N.1): collaborator

Study Sites (2)

National University Hospital

Singapore, Singapore

RECRUITING

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

Singapore, Singapore

RECRUITING

Related Publications (4)

• 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.

  BACKGROUND

• 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.

  PMID: 27053773 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 37879700 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Neoplasms

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Dr Balamurugan A Vellayappan

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Balamurugan A Vellayappan

CONTACT

+65 67795555; bala_vellayappan@nuhs.edu.sg

Qian Yee, Queenie Chai

CONTACT

queenie_qy_chai@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: April 19, 2021
• Study Start: June 14, 2021
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2022
• Last Updated: November 12, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)