PTI-125 for Mild-to-moderate Alzheimer's Disease Patients
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|ClinicalTrials.gov Identifier: NCT03748706|
Recruitment Status : Completed
First Posted : November 21, 2018
Last Update Posted : September 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: PTI-125, 100 mg tablets||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2a, Open-label, Multiple Dose, Safety, Pharmacokinetic and Biomarker Study of PTl-125 in Mild-to-moderate Alzheimer's Disease Patients|
|Actual Study Start Date :||March 7, 2019|
|Actual Primary Completion Date :||May 8, 2019|
|Actual Study Completion Date :||May 8, 2019|
PTI-125 100 mg oral tablets administered twice daily (BID)
Drug: PTI-125, 100 mg tablets
PTI-125, 100 mg tablets taken twice a day for 28 days
- Maximum Plasma Concentration (Cmax) [ Time Frame: Study Days 1, 2, 28 and 29 ]Blood draws will be done to evaluate levels of PTI-125 in the plasma using non-compartmental methods in WinNonlin.
- Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Study Days 1, 2, 28 and 29 ]Levels of PTI-125 will be assessed to determine how long it takes to reach the Cmax
- Last Quantifiable Plasma Concentration (Clast) [ Time Frame: Study Day 1, 2, 28 and 29 ]Levels of PTI-125 will be assessed to determine the last time point where PTI-125 can be detected.
- Time to Last Quantifiable Plasma Concentration (Tlast) [ Time Frame: Study Days 1, 2, 28 and 29 ]Levels of PTI-125 will be assessed to determine the elapsed time to where PTI-125 can last be detected in the plasma.
- Area Under the Curve (AUC) [ Time Frame: Study Days 1, 2, 28 and 29 ]AUC for PTI-125 plasma concentration from time zero to the last quantifiable plasma concentration.
- Minimum Plasma Concentration (Cmin) [ Time Frame: Study Days 7 and 14 ]Assessment of the lowest plasma concentration of PTI-125
- PTI-125DX (biomarker) [ Time Frame: Study Days 1, 7, 14 and 29 ]Blood samples will be tested for the companion diagnostic/biomarker for Alzheimer's disease.
- Biomarker assay [ Time Frame: Day 28 ]A cerebrospinal fluid sample collection will be performed for Aβ/tau, YKL40 and other potential CSF biomarkers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748706
|United States, Texas|
|Insite Clinical Research|
|DeSoto, Texas, United States, 75115|
|Clinical Trials of Texas|
|San Antonio, Texas, United States, 78229|
|Study Director:||Lindsay Burns, PhD||Cassava Sciences, Inc.|