Hearing profiling in early Alzheimer's and Parkinson's

Phenotyping of Audition in Patients With Early Stage of Neurodegenerative Disorders (Alzheimer and Parkinson' Diseases)

This project will test detailed hearing tests to see if people with early Alzheimer's or Parkinson's have hidden hearing loss compared with healthy older adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 309 (estimated)
• Ages: 50 Years to 85 Years
• Sex: All
• Sponsor: Cilcare SAS (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 4 sites (Montpellier and 3 other locations)
• Trial ID: NCT07083089 on ClinicalTrials.gov

What this trial studies

Participants aged 50–85 who are fluent in French will undergo a comprehensive battery of subjective and objective hearing tests, including tonal and speech audiometry in silence and noise, distortion-product otoacoustic emissions (DPOAE), acoustic reflexes, and electrophysiology (auditory brainstem response and electrocochleography). The study specifically looks for speech-in-noise intelligibility deficits despite normal tonal audiograms (so-called hidden hearing loss). Hearing results will be correlated with clinical disease measures and blood biomarkers to search for patterns linked to early neurodegeneration. Healthy control participants are included for comparison and testing is performed at three French university hospital sites.

Who should consider this trial

Good fit: Ideal candidates are French-speaking adults aged 50–85 who can travel to one of the participating French university hospitals, are insured under French public health insurance, can give informed consent, and either meet criteria for amnestic MCI (NIA‑AA with specified memory test scores), have an established Parkinson's diagnosis per Postuma et al. 2015, or are healthy controls.

Not a fit: Patients with advanced dementia or advanced Parkinson's disease, those unable to complete or tolerate detailed hearing testing, non–French speakers, those outside the 50–85 age range, or those without French public health insurance are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the work could identify hearing-related biomarkers that help detect or better manage communication problems in early Alzheimer's and Parkinson's disease.

How similar studies have performed: Previous research has used similar audiological and electrophysiological approaches and found links between speech-in-noise deficits and neural auditory dysfunction, but candidate biomarkers remain exploratory and not yet established for clinical use.

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 tremor or rigidity, no exclusion criteria or red flag with MOCA ≥23.

For controls:

No diagnosis of neurological disease such as Parkinson's disease or MCI associated or not with Alzheimer's disease Displays normal cognitive status with a MoCA score ≥ 26.

Non-inclusion criteria:

1. Known hearing pathologies leading to conductive hearing loss (otosclerosis, a diagnosed pathology of the ear canal, tympanic membrane, ossicles or 3rd window), otitis, congenital deafness or sensorineural hearing loss associated to Menière's disease.
2. Psychiatric diseases other than neurodegenerative etiology
3. Neurological or neurovascular disorders (Stroke, epilepsy, dementia)
4. Motor complications that could interfere with audiological assessment
5. Known Diagnosis of type 2 diabetes
6. Alcohol or drug addiction
7. Cochlear implant
8. Known ototoxic drug therapy:

   1. Antibiotics: Aminosides IV, macrolides, tetracyclines in the last 15 days prior to inclusion
   2. Antipaludic drugs: quinine, hydroxychloroquine, chloroquine in the last 15 days prior to inclusion
   3. Platinum-based chemotherapy at any time prior to inclusion.
   4. Loop diuretics: furosemide (max oral dose of ≤60mg/day) at inclusion and during the study.
   5. Salicylate derivatives at high dose (Kardegic allowed at dose ≤320mg/day) at inclusion and during the study.
9. History of otological surgical act.
10. On-going pregnancy or breast-feeding.
11. Adults protected by law: in vulnerable social situations or unable to express consent.
12. Under another protocol that may interfere with the analysis of the results.

Exclusion Criteria:

Patients will be excluded from the study if one or more of the following criteria are applicable during visit 2:

1. Abnormal otoscopy as defined by less than 90% of the tympanic membrane visible (cerumen ear plug, ear drum perforation, …)
2. Conductive hearing loss defined by an air-bone threshold gap of 10 dB or greater based on the average of frequencies 0.5, 1, 2, and 4 kHz, and abnormal hearing thresholds (greater than 20 dB HL) for these frequencies.
3. Abnormal tympanogram (other type than A)
4. Asymmetric hearing loss: more than 15 dB difference in the pure-tone average (PTA) air conduction (for MCI patients and control group only)
5. Single-sided deafness (SSD)
6. Cophosis (PTAv \> 120 dB)

Where this trial is running

Montpellier and 3 other locations

• CHU Gui de Chauliac — Montpellier, France (Recruiting)
• CHU Nice — Nice, France (Recruiting)
• CHU Carémeau — Nîmes, France (Recruiting)
• Hospices Civils de Lyon, Hôpital des Charpennes — Villeurbanne, France (Recruiting)

Study contacts

• Study coordinator: Laura BREDA, Master's degree

Conditions Mild Cognitive Impairment Amnestic; Parkinson Disease; Healthy Participants; hearing phenotype; audiometry; speech-in-noise intelligibility; electrophysiology