Could a common Alzheimer's drug help people hear better with cochlear implants?
NCT ID NCT05438264
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tests whether donepezil, a drug used for Alzheimer's, can improve speech recognition in adults who already use a cochlear implant. Researchers think the drug may help the brain adapt to the implant's signals. Fifty participants will receive either donepezil or a placebo for three months, and their hearing and thinking skills will be measured.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Donepezil (also known as Aricept)
- What this could lead to
- If it works, this could point toward a medication that helps cochlear implant users hear speech more clearly.
- What could go wrong
- This is a very early, small trial. The drug may not improve hearing, and side effects like nausea or dizziness are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2023
- Expected to finish
-
Sep 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 100 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. At least 6 months of cochlear implant use 2. Age ≥ 18 years 3. Post-lingual onset of deafness 4. Audiometric thresholds meeting FDA-labeled indications for adult cochlear implantation 5. Normal or corrected-to-normal vision assessed with a Snellen eye chart 6. English verbal communication 7. No participation in any other clinical trial within the past 3 months 8. Physically healthy 9. Female participants must have no child-bearing potential or agree to practice effective contraception during the study (such as established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; condom with spermicidal foam/gel/film/cream/suppository; occlusive cap with spermicidal foam/gel/film/cream/suppository; male partner sterilization; or true abstinence when this is in line with the preferred and usual lifestyle of the subject) 10. Female participants of child-bearing potential must have a negative urine pregnancy test at the time of enrollment and before each study visit Exclusion Criteria: 1. Evidence of conductive hearing loss 2. Diagnosed neurological or sensory disorder (such as Alzheimer's disease, Parkinson's disease, epilepsy, stroke, autism, schizophrenia, or uncorrected visual impairment) 3. Positive urine pregnancy test at any time during the study 4. Breastfeeding or nursing at any time during the study 5. Known hypersensitivity to donepezil hydrochloride or to piperidine derivatives 6. Current use of medications with known anticholinergic effects (such as tricyclic antidepressants, first-generation antihistamines, or bladder antispasmodics) 7. Current or prior use of cholinesterase inhibitors 8. Use of tobacco or nicotine products in the past 1 month 9. Severe anatomic abnormalities of the temporal bone 10. Major active life-threatening illness
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A free app might sharpen hearing after cochlear implants — trial puts it to the test
- New hearing aid algorithm aims to cut through noise for clearer speech
- Brain scans may forecast language success in children with cochlear implants
- Hearing aid microphone showdown: which helps you hear better in noise?
- New study aims to unlock secrets of hearing in noise for cochlear implant users
- Virtual reality reveals how kids with cochlear implants pinpoint sounds in 3D