Parley Neurotech

Parley Neurotech Enrolls First Patient in Clinical Trial Targeting the #1 Modifiable Risk Factor for Dementia

Beating every published Phase II benchmark with 229 days from IND submission to first enrollment — in an indication with 800 million patients and no approved treatment

DENVER, CO — Parley Neurotech (3000 Lawrence St, Denver, CO 80205) today announced enrollment of its first volunteer in the CAPD-LOOT trial (NCT07304024),1 a double-blind, placebo-controlled, randomized Phase I/IIa study of a first-in-class combination therapy for age-related central auditory processing disorder (CAPD). No FDA-approved treatment exists for this condition.

AN UNADDRESSED MARKET AT THE CENTER OF THE DEMENTIA CRISIS
The 2024 Lancet Commission on Dementia Prevention identifies untreated hearing loss as the single largest modifiable risk factor for dementia. According to this commission, treating hearing loss could prevent 1 in 12 dementia cases globally. 2 Age-related CAPD, defined by the inability to understand speech in background noise despite intact peripheral hearing, represents the highest-risk subtype, with affected individuals facing nearly twice the risk of cognitive decline (HR=1.91).² The condition affects approximately 800 million people worldwide, including just under 60 million Americans. No therapeutic treatment exists for this neurological condition; available assistive devices amplify sound but do not address its biological cause, and published evidence documents that even patients prescribed hearing aids for co-occurring peripheral loss frequently fail to achieve meaningful speech-in-noise benefit, limiting the protective effect.³ Parley's LOOT platform is the first clinical candidate for this population.

THE THERAPY AND ITS PRECLINICAL BASIS
LOOT (Localized Oligodendrocyte Optimization Therapy) combines clemastine fumarate, an oral FDA-approved drug being evaluated as a potential remyelinating agent, with proprietary acoustic therapy delivered for 60 minutes daily. In preclinical models of age-related CAPD, the combination produced near-complete reversal of the deficit within 30 days. Neither component alone replicated this result. The clemastine dosage is identical to that established safe across multiple Phase II multiple sclerosis trials, substantially de-risking the safety component of the current study.

OPERATIONAL EXECUTION: IND SUBMISSION TO FIRST PATIENT IN 229 DAYS
Parley submitted IND #178635 on August 15, 2025. FDA issued study-may-proceed clearance 25 days later. First enrollment occurred April 1, 2026 — 229 days from IND submission. The NCI Operational Efficiency Working Group, after a coordinated multi-institutional effort to accelerate trial activation, achieved a reformed Phase I-II median of 442 days, down from a historical median of 541 days.⁴ Published industry benchmarks place Phase II time from site selection to first patient at 7.9 to 12.9 months.⁵ Parley's 229 days falls below both — at a major academic medical center, with a novel combination product, two factors consistently associated with longer timelines in the published literature. Enrollment opened with all staff training complete, third-party monitoring aligned, and proprietary endpoint measurement software validated against final standard operating procedures.

TRIAL DESIGN AND NEAR-TERM CATALYSTS
The CAPD-LOOT trial enrolls up to 344 volunteers across four arms in an FDA-endorsed adaptive design that includes predefined interim analyses permitting early termination for success. The first such interim — at which the trial can declare success if the observed effect approaches preclinical magnitude — is triggered at approximately 60 enrolled participants. Parley has already pre-screened that many volunteers, who are ready to enroll. Primary endpoints are objective, quantitative, psychophysical measures of speech-in-noise performance; secondary endpoints
include validated patient-reported outcomes and a physiological remyelination measure.

FUNDING AND INSTITUTIONAL CONTEXT
Basic science and pre-clinical developments are supported in part by NIH grants. First enrolled patients and Parley's commercialization efforts are supported by CU Innovations via a SPARK award.^6,7 The trial is conducted at the University of Colorado Anschutz Medical Campus, which hosts approximately 3,800 active clinical trials — roughly 15% of all active trials in the United States^8,9 — and ranks 5^th among research hospitals globally in health sciences by Nature.¹⁰

RECRUITMENT STATUS
Parley is actively enrolling additional volunteers as funding milestones are reached. The pre-screened cohort of 60 volunteers is committed and ready to enroll, eliminating the recruitment lag that typically extends Phase II timelines. The first interim analysis, at which the trial can declare success, is triggered at approximately 60 enrolled participants. Prospective volunteers who struggle to hear in noisy environments are encouraged to visit researchstudies.cuanschutz.edu/Study/25-1184.

Parley Neurotech is a clinical-stage neurotechnology company developing the first treatment for age-related central auditory processing disorder, the condition identified by the Lancet Commission as the single largest modifiable risk factor for dementia. The company was founded by Achim Klug, PhD, Chief Scientific Officer and Professor of Physiology and Biophysics at CU Anschutz, whose laboratory originated the science underlying LOOT, and Samuel Budoff, PhD, CEO, who holds a PhD in Neuroscience, master's degrees in Applied Statistics and Neuroengineering, and and postdoctoral researcher in the Klug Lab. Parley is headquartered in Denver, Colorado.

1. CAPD-LOOT Trial Registration — NCT07304024 https://clinicaltrials.gov/study/NCT07304024
2. Lancet Commission on Dementia Prevention 2024 — Hearing Loss as #1 Modifiable Risk Factor
   https://www.thelancet.com/article/S0140-6736(24)01296-0/abstract
3. Hearing Aid Speech-in-Noise Algorithm Limitations and Compliance (PMC9647784)
   https://pmc.ncbi.nlm.nih.gov/articles/PMC9647784/
4. NCI Operational Efficiency Working Group — Phase I-II Median 541 → 442 days (PMID 23776198)
   https://pmc.ncbi.nlm.nih.gov/articles/PMC3699438/
5. Applied Clinical Trials / Tufts CSDD — Phase II Benchmark (7.9–12.9 months)
   https://www.appliedclinicaltrialsonline.com/view/survey-results-start-cycle-times
6. CU Innovations — First-of-its-Kind Treatment for Brain-Based Hearing Loss
   https://news.cuanschutz.edu/cu-innovations/first-of-its-kind-treatment-for-brain-based-hearing-loss
7. CU Innovations SPARK Program Fellows
   https://www.cuanschutz.edu/innovations/spark/who-are-we/fellows
8. CU Anschutz — 3,800 Active Clinical Trials (September 2025)
   https://news.cuanschutz.edu/medicine/research-series-intro-2025
9. ClinicalTrials.gov — Active U.S. Trial Count
   https://clinicaltrials.gov/search?locStr=United%20States&country=US&aggFilters=status:not%20rec&viewType
   =Card
10. Nature Index 2025 — Research Hospitals (Health Sciences)
    https://www.nature.com/nature-index/supplements/nature-index-2025-research-hospitals/tables/health-sciences