What is Clemastine Fumarate studying for age-related central auditory processing disorder?

Clemastine Fumarate is being studied to see if it can improve hearing difficulties in noisy environments for people with age-related central auditory processing disorder. The study combines the drug with specially designed sound to test if this approach can help restore nerve function involved in hearing. The University of Colorado, Denver is leading the research to understand this potential treatment.

Who may be eligible for this central auditory processing disorder clinical trial?

Adults aged 45 to 65 with mild hearing loss and normal middle-ear function may be eligible. Participants must have difficulty hearing in noise and no significant cognitive issues. Both men and women can join. People with certain medical conditions or sensitivities to the study drug will not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this central auditory processing disorder clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs related to travel or accommodations.

Actively Recruiting

Phase 1

Phase 2

Age: 45Years - 65Years

All Genders

ID07304024

Testing the Safety and Effectiveness of Clemastine Fumarate with Engineered Sound to Treat Age-Related Central Auditory Processing Disorder in Adults Aged 45 to 65

Led by University of Colorado, Denver · Updated on 2026-04-30

344

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the use of Clemastine Fumarate combined with engineered sound to treat age-related central auditory processing disorder CAPD, a condition affecting many people over 40 and causing difficulty hearing in noisy environments. This trial aims to test if the therapy, called Localized Oligodendrocyte Optimization Therapy LOOT, which showed promise in animal studies, can improve hearing in noise for humans. The study is designed to compare the effectiveness of the drug with or without engineered sound in a controlled, randomized setting. Participants will be randomly assigned to one of four groups Clemastine Fumarate with engineered sound, Clemastine Fumarate with placebo sound white or pink noise, placebo drug with engineered sound, or placebo drug with placebo sound. The drug dosage is carefully controlled and given orally over 30 days, while participants listen to the assigned sound stimulation through headphones for one hour daily. The trial includes an adaptive design allowing adjustment of study arms based on interim results. Throughout the study, participants will undergo hearing tests to measure their ability to hear in noisy environments, both before and after treatment. Additional assessments include questionnaires on speech and tinnitus, auditory brainstem response tests, physical exams, blood tests, and EKGs to monitor health and safety. The treatment period lasts one month, with evaluations scheduled around weeks five or six. Safety and hearing improvements are carefully monitored to assess the therapys impact.

CONDITIONS

Brief Title

A Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound

Who Can Participate

Age: 45Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

Male or female between 45 and 65 years old at screening/enrollment
Ability to provide written informed consent and comply with study requirements
Mild or less high-frequency hearing loss with normal middle-ear function confirmed by audiologist
Bilateral hearing thresholds below 20 dB HL from 250 Hz to 4000 Hz, no air-bone gaps over 10 dB
Symmetrical hearing thresholds between ears through 8000 Hz
Normal Type A tympanograms bilaterally
No cognitive deficit on Montreal Cognitive Assessment (MOCA)
Distortion product otoacoustic emission showing no more than 20 dB hearing loss from 250 Hz to 4000 Hz
Failed hearing in noise test at 15 degrees, defined as signal-to-noise ratio 12 dB below normal

You will not qualify if you...

Any condition not meeting the inclusion criteria
Known allergy to clemastine fumarate or similar antihistamines
Pregnancy or nursing, confirmed by urine pregnancy test
Lower respiratory diseases like asthma, emphysema, or chronic bronchitis
Glaucoma or increased eye pressure
Stenosing peptic ulcers or pyloroduodenal obstruction
Trouble urinating due to enlarged prostate (except mild cases with warning)
Significant cardiovascular disease, uncontrolled blood pressure
Hyperthyroidism
Alcoholism defined by consumption or diagnosis
History of seizures
Suicidal ideation or behavior assessed by Columbia Suicide Severity Rating Scale
Significant or uncontrolled medical disorders including hepatic, hematologic, renal, gastrointestinal, neurological, psychiatric conditions
Abnormal blood counts or metabolic panels outside specified ranges
Use of monoamine oxidase inhibitors or CNS depressants
History of significant ear disorders like repeated infections or Meniere's disease
History of significant neurological disorders or neurodegenerative diseases
History of traumatic brain or closed head injury
Non-native English speakers
Any other condition that may compromise safety or data quality as judged by investigators

Research Team

Ajay Keerthy, BS

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