Clinical trial · Interventional
CURATE.AI COR-Tx Trial for Post Brain Radiotherapy Patients
CURATE.AI Optimised Digital COgnitive Rehabilitation Therapy (COR-Tx) for Post Brain Radiotherapy Patients: CURATE.AI COR-Tx Mixed-methods Feasibility Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Decline | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CURATE.AI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CURATE.AI
- description
- 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.
- interventionNames
- Device: CURATE.AI
Primary outcomes (7)
- measure
- Patient acceptability of the digital cognitive test battery DI/DD obtained during a semi-structured interview
- timeFrame
- One visit 60 minutes (at the end of the 10 week intervention)
- description
- Qualitative summary of patient acceptability of the digital cognitive test battery DI/DD
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (4)
- BACKGROUNDKee, 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.
- BACKGROUNDZarrinpar 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
- BACKGROUNDPantuck 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.
- DERIVEDRemus 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