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Portuguese company developing a test for Early Stage Detection of Cognitive Decline is looking for clinical trial partners

Summary

Profile Type
  • Research & Development Request
POD Reference
RDRPT20240710002
Term of Validity
10 July 2024 - 10 July 2025
Company's Country
  • Portugal
Type of partnership
  • Research and development cooperation agreement
Targeted Countries
  • All countries
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General information

Short Summary
A Portuguese company developing virtual reality solutions for cognitive assessment, training and monitoring is looking for partners. Aiming to enhance its cognitive assessment VR tool by integrating AI/ML to analyse complex gameplay datasets for the definition of a gameplay classification system capable of categorizing users and detect the earliest signs of cognitive decline in individuals aged 55+. The company is seeking clinical partners to support data collection.
Full Description
Cognitive functioning deteriorates with age and can be exacerbated by age-related neurodegenerative diseases, such as Alzheimer's disease and related dementias. Early signs and symptoms of cognitive impairment are often subtle and not objectively measurable, being frequently overlooked by either the patients and their families but also dismissed by the physicians. Current cognitive screening tests are reliable tools to screen for cognitive impairment, but present limitations, particularly the lack of sensitivity to detect early stages of cognitive decline, like subjective cognitive decline (SCD).
The project the company is developing is a brief cognitive screening test in virtual reality to quantify the cognitive abilities of the individual sensitively and accurately, aiming to identify the earliest manifestations of cognitive decline. The project seeks to enhance the performance of the screening test by integrating AI algorithms to tailor the gameplay classification system by analyzing complex gameplay datasets, enabling patient categorization and contributing towards a more sensitive detection of the earliest signs of cognitive decline in individuals aged 55 and above. To do so, a randomized pivotal clinical study involving 1000 (TBD) participants will be conducted. This cognitive, motor, and behavioral data will lay the foundation for developing VR-based digital biomarkers of cognitive decline. Additionally, the data will support the certification of the test as a medical device under the European Medical Device Regulation (MDR 2017/745).
Advantages and Innovations
Brief cognitive screening tests like the Montreal Cognitive Assessment (MoCA) and the Mini-Mental State Examination (MMSE) are reliable for detecting cognitive impairments such as Mild Cognitive Impairment (MCI), often a precursor to dementia. However, these traditional standards have significant limitations. They often fail to detect early cognitive decline, due to ceiling effects and they lack ecological validity; the pen-and-paper format presents abstract tasks that don't resemble everyday activities, making it hard to measure real-world cognitive skills. Moreover, these tests are examiner-dependent, leading to subjective evaluations and a reliance on single cutoff scores to assess cognitive status.
Virtual Reality (VR) scenarios offer a promising alternative by providing ecologically valid environments with precise control over experimental variables. These scenarios have been effective in assessing cognitive functions in patients with cognitive impairments. Unlike traditional methods, VR environments can collect a vast amount of detailed data, including behavioral patterns and responses, beyond just single cut-off values from tests. This test not only evaluates performance on individual tasks but also logs extensive behavioral data and gameplay patterns. This comprehensive data collection enables more sensitive detection of changes in both cognitive and psychomotor performance. VR’s immersive and interactive nature can provide a more accurate and less stressful assessment experience, potentially leading to earlier and more precise identification of cognitive decline.
Technical Specification or Expertise Sought
The company is seeking clinical partners to conduct the clinical study. The study protocol is still being discussed internally and enrolled clinical partners are expected to contribute to the study design. We expect the study to be a randomized pivotal clinical study involving 1000 (TBD) participants who will be assigned to the following groups: i) no cognitive complaints, ii) subjective cognitive complaints, iii) diagnosed with MCI, iv) diagnosed with dementia. The gameplay profile of each population will be defined and compared among groups, allowing the stratification of the patients and, eventually, the identification of digital biomarkers of early-stage cognitive decline. The inclusion and exclusion criteria are still TBD.
Stage of Development
  • Available for demonstration
Sustainable Development Goals
  • Goal 3: Good Health and Well-being
IPR status
  • No IPR applied

Partner Sought

Expected Role of a Partner
We are seeking clinical partners capable of recruiting 250-300 participants per arm, ideally with experience in European R&D projects. Geographical distribution of the clinical sites will be taken into consideration, so cultural and biological characteristics are mitigated when analyzing participants gameplay data.
Type and Size of Partner
  • Other
Type of partnership
  • Research and development cooperation agreement

Call details

Framework program
  • Access to finance
Call title and identifier
Access to finance
Anticipated project budget
1,500,000€
Coordinator required
No
Deadline for EoI
Deadline of the call
Project duration in weeks
156

Dissemination

Market keywords
  • 05001001 - Diagnostic services
Targeted countries
  • All countries