NCT07083089 Early Stage of Alzheimer's and Parkinson's Diseases, HearIng Relevance (SAPHIR)
| NCT ID | NCT07083089 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cilcare SAS |
| Condition | Mild Cognitive Impairment (MCI) Amnestic |
| Study Type | INTERVENTIONAL |
| Enrollment | 309 participants |
| Start Date | 2025-03-24 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The study aims to phenotype hearing in patients with early stage of neurodegenerative disorders to explore the prevalence of various hearing disorders in comparison to a control population. Specific focus is made on patients with speech-in-noise intelligibiltiy deficit despite normal tonal audiograms referred to as hidden hearing loss, with potential identification of associated biomarkers.
Eligibility Criteria
Inclusion Criteria: All subjects 1. Man or woman aged between 50 and 85 years old at baseline. 2. Fluent in French (native language) 3. Be considered as reliable and capable of adhering to the protocol, according to the judgment of the investigator (understanding of the information included in the protocol, and requests to realize the investigations, good general health and able to move around). 4. Affiliated to Public Health Insurance (Sécurité Sociale) 5. Signed and dated informed consent form. For amnestic MCI: Diagnosis of amnestic MCI, according to international diagnosis criteria (NIA-AA, 2011) with MoCA≥23 or MMSE\>24.Patients must exhibit predominantly cognitive impairments in episodic memory, defined by a score on the RL/RI 16-item test with a free recall score of less than 18/48 and a total recall score of less than 40/48. For Parkinson Patients: Established clinical diagnosis of Parkinson's disease according to Postuma et al. 2015 with bradykinesia associated with resting tr