NCT03748706

PTI-125 for Mild-to-moderate Alzheimer's Disease Patients

A Phase 2a, Open-label, Multiple Dose, Safety, Pharmacokinetic and Biomarker Study of PTl-125 in Mild-to-moderate Alzheimer's Disease Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Pain Therapeutics · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2a, multi-center, open-label study of PTI-125 in mild-to-moderate Alzheimer's disease patients.

Detailed description

This is a Phase 2a, multi-center, open-label study of PTI-125 in mild-to-moderate AD patients, 50-85 years of age. A total of twelve (12) patients will be enrolled into the study. Patients will receive 100 mg b.i.d. of PTI-125. The objectives of this study are to investigate the safety, pharmacokinetics and effect on biomarkers of PTI-125 following 28-day repeat-dose oral administration.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	PTI-125, 100 mg tablets	PTI-125, 100 mg tablets taken twice a day for 28 days

Timeline

• Start date: 2019-03-07
• Primary completion: 2019-05-08
• Completion: 2019-05-08
• First posted: 2018-11-21
• Last updated: 2021-07-07
• Results posted: 2021-04-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study