our clinical studies
Cilcare launched a series of prospective observational studies in 2023 aiming to collect auditory data from different subpopulations of patients with defined conditions in view of better characterizing their hearing impairments using subjective and objective biomarkers.
Indeed, due to a number of physiopathological mechanisms leading to cochlear damage, one approach to solve the issue of patient selection in interventional clinical trials is to define subpopulations of people at risk for hearing loss and suffering from underlying pathologies that are well characterized.
Observational studies
Sensorineural hearing loss is particularly common in individuals with neuro-inflammatory diseases, with various underlying causes, including cochlear synaptopathy, which leads to difficulty in understanding speech in noisy environments.
Diabetes, affecting 530 million people worldwide, is linked to kidney failure, cardiovascular issues, and neuropathy, with diabetics being twice as likely to experience hearing loss. Prediabetics have a 30% higher risk. While the exact cause is unclear, studies suggest inflammation, vascular issues, and neuropathy may contribute to hearing damage in these patients.
Hearing impairment in later life is a significant critical concern and a leading factor in cognitive decline, particularly for those with neurodegenerative diseases like Alzheimer’s and Parkinson’s. With hearing loss identified as the leading modifiable risk factor for dementia prevention, these findings highlight the essential role of auditory health in preventing cognitive decline, reinforcing the need for earlier detection and intervention strategies.
DIAMANT: characterizing the auditory profile of diabetic patients
The objective of the DIAMANT study is to characterize cochlear synaptopathy in patients with Type 2 Diabetes Mellitus. Endpoints include speech recognition, auditory neuropathy, otoacoustic emissions, and acoustic reflex thresholds. Correlations will be examined between auditory readouts and biochemical parameters such as glycemia (HbA1c), dyslipidemia, kidney functions, and inflammation.
DIAMANT's study design (DIAbetes Mellitus, AuditioN function profiling, Type 2)
Study centers
If you are interested in learning more, please email us for more information at info@cilcare.com
Link to 2023 Press Release
SAPHIR: characterizing the auditory profile of patients with neurodegenerative diseases
The objective of the SAPHIR trial is to investigate the prevalence of cochlear synaptopathy in people with early-stage neurodegenerative diseases (Amnestic Mild Cognitive Impairment and Parkinson’s), versus a control group. The study will enroll 309 participants aged between 50 & 85 years old, divided into 3 groups:
1/ Amnestic MCI of neurodegenerative origin (e.g., – Alzheimer’s disease)
2/ Parkinson’s disease patients
3/ Age-matched control group
Participants will follow a protocol that includes blood tests, cognitive assessments, and auditory evaluations across three visits, with an optional visit to review their hearing assessment with an ENT specialist.
The primary objective is to compare the prevalence of cochlear synaptopathy among the three groups, identified by speech-in-noise deficits in the presence of a normal or slightly altered pure-tone audiogram. Secondary objectives include comparing other hearing disorders (sensorineural hearing loss, auditory neuropathy, and speech comprehension deficits) across groups, as well as studying asymmetric hearing loss in Parkinson’s patients and its link to motor symptoms. The study will also assess the prevalence of hearing disorders across different frequencies and explore associations between auditory profiles—including cochlear synaptopathy—and Alzheimer’s disease, in relation to plasma biomarkers.
SAPHIR Study design (early Stage of Alzheimer’s and Parkinson’s diseases, HearIng Relevance)
Study centers
Link to 2025 Pres Release
The results of the DIAMANT & SAPHIR studies will be used to refine the phase 1b/2a clinical study protocols planned with CIL001, Cilcare’s lead candidate for the treatment of cochlear synaptopathy, clinically characterized by speech-in-noise intelligibility deficit in the presence of normal audiometric thresholds.
Upcoming Phase 2A interventional trials with CIL001
Cilcare is actively advancing the clinical development of CIL001 with 3 Phase 1b/2a trials aimed at addressing cochlear synaptopathy in different patient populations. These studies will assess the safety and efficacy of CIL001, administered through a single intratympanic injection:
Study #1: focuses on Restoring Speech-in-noise intelligibility in patients with Type-2 Diabetes
Study #2: focuses on restoring the connection of auditory Synapses in patients with Parkinson’s and Alzheimer’s diseases with speech-in-Noise intelligibility deficit
Study #3: aims to treat Cochlear synaptopathy in Tinnitus patients by restoring the connection of auditory synapses
The study #1 is scheduled to begin in late 2025 across multiple sites in Europe and the US, while studies #2 and #3 are expected to launch in 2026 in different countries.
