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Could a common Alzheimer's drug help people hear better with cochlear implants?

NCT ID NCT05438264

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

Hearing Loss, Sensorineural sensorineural hearing loss disorder

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.