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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748706
Recruitment Status : Completed
First Posted : November 21, 2018
Results First Posted : April 1, 2021
Last Update Posted : July 7, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Cassava Sciences, Inc. ( Pain Therapeutics )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Alzheimer Disease
Intervention Drug: PTI-125, 100 mg tablets
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PTI-125
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PTI-125 100 mg oral tablets administered twice daily (BID)

PTI-125, 100 mg tablets: PTI-125, 100 mg tablets taken twice a day for 28 days

Period Title: Overall Study
Started 13
Completed 12
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title PTI-125
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PTI-125 100 mg oral tablets administered twice daily (BID)

PTI-125, 100 mg tablets: PTI-125, 100 mg tablets taken twice a day for 28 days

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
67.8
(56 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
9
  69.2%
Male
4
  30.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  23.1%
White
10
  76.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
 100.0%
1.Primary Outcome
Title Maximum Plasma Concentration (Cmax)
Hide Description Blood draws will be done to evaluate levels of PTI-125 in the plasma using non-compartmental methods in WinNonlin.
Time Frame Study Day 1 and Day 28 at 20, 40, and 60 min and at 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 h post-dose
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title PTI-125
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PTI-125 100 mg oral tablets administered twice daily (BID)

PTI-125, 100 mg tablets: PTI-125, 100 mg tablets taken twice a day for 28 days

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 1 Cmax 1020  (442)
Day 28 Cmax 1100  (417)
2.Primary Outcome
Title Time to Maximum Plasma Concentration (Tmax)
Hide Description Levels of PTI-125 will be assessed to determine how long it takes to reach the Cmax
Time Frame Study Day 1 and Day 28 at 20, 40, and 60 min and at 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PTI-125
Hide Arm/Group Description:

PTI-125 100 mg oral tablets administered twice daily (BID)

PTI-125, 100 mg tablets: PTI-125, 100 mg tablets taken twice a day for 28 days

Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: hours
Day 1 Tmax
2.00
(1.00 to 3.00)
Day 28 Tmax
2.06
(1.00 to 5.93)
3.Primary Outcome
Title Last Quantifiable Plasma Concentration (Clast)
Hide Description Levels of PTI-125 will be assessed to determine the last time point where PTI-125 can be detected.
Time Frame Study Day 1 and Day 28 at 20, 40, and 60 min and at 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PTI-125
Hide Arm/Group Description:

PTI-125 100 mg oral tablets administered twice daily (BID)

PTI-125, 100 mg tablets: PTI-125, 100 mg tablets taken twice a day for 28 days

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 1 Clast 176  (112)
Day 28 Clast 238  (168)
4.Primary Outcome
Title Time to Last Quantifiable Plasma Concentration (Tlast)
Hide Description Levels of PTI-125 will be assessed to determine the elapsed time to where PTI-125 can last be detected in the plasma.
Time Frame Study Day 1 and Day 28 at 20, 40, and 60 min and at 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PTI-125
Hide Arm/Group Description:

PTI-125 100 mg oral tablets administered twice daily (BID)

PTI-125, 100 mg tablets: PTI-125, 100 mg tablets taken twice a day for 28 days

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: hours
Day 1 Tlast 12.0  (0.0150)
Day 28 Tlast 12.0  (0.0285)
5.Primary Outcome
Title Area Under the Curve (AUClast)
Hide Description AUC for PTI-125 plasma concentration from time zero to the last quantifiable plasma concentration.
Time Frame Study Day 1 and Day 28 at 20, 40, and 60 min and at 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PTI-125
Hide Arm/Group Description:

PTI-125 100 mg oral tablets administered twice daily (BID)

PTI-125, 100 mg tablets: PTI-125, 100 mg tablets taken twice a day for 28 days

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Day 1 AUClast 5320  (2230)
Day 28 AUClast 6700  (3240)
6.Primary Outcome
Title Plasma Half-life (T1/2)
Hide Description Assessment of the half-life in plasma of PTI-125
Time Frame Study Day 1 and Day 28 at 20, 40, and 60 min and at 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PTI-125
Hide Arm/Group Description:

PTI-125 100 mg oral tablets administered twice daily (BID)

PTI-125, 100 mg tablets: PTI-125, 100 mg tablets taken twice a day for 28 days

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: hours
Day 1 T1/2 4.51  (2.43)
Day 28 T1/2 4.35  (1.39)
7.Secondary Outcome
Title SavaDx (Biomarker)
Hide Description Blood samples will be tested for the complementary diagnostic/biomarker for Alzheimer's disease.
Time Frame Study Day 1 and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PTI-125
Hide Arm/Group Description:

PTI-125 100 mg oral tablets administered twice daily (BID)

PTI-125, 100 mg tablets: PTI-125, 100 mg tablets taken twice a day for 28 days

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: % change from baseline
-39.8  (0.19)
8.Secondary Outcome
Title CSF Biomarkers
Hide Description A cerebrospinal fluid sample collection will be performed for Aβ42, tau, YKL40 and other potential CSF biomarkers
Time Frame Change from Baseline to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PTI-125
Hide Arm/Group Description:

PTI-125 100 mg oral tablets administered twice daily (BID)

PTI-125, 100 mg tablets: PTI-125, 100 mg tablets taken twice a day for 28 days

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: % change from baseline
Total tau -19.8  (0.04)
Abeta42 4.3  (0.05)
p-tau181 -34.4  (0.05)
Neurogranin -32  (0.02)
Neurofilament light chain -22  (0.02)
YKL-40 -9  (0.01)
IL-6 -14  (0.01)
IL-1 beta -11  (0.01)
TNF alpha -5  (0.01)
Time Frame Within the 28-day treatment period.
Adverse Event Reporting Description Moderate; mild; severe Serious; not serious Unlikely; likely; possibly related to drug treatment
 
Arm/Group Title PTI-125
Hide Arm/Group Description

PTI-125 100 mg oral tablets administered twice daily (BID)

PTI-125, 100 mg tablets: PTI-125, 100 mg tablets taken twice a day for 28 days

All-Cause Mortality
PTI-125
Affected / at Risk (%)
Total   0/13 (0.00%)    
Hide Serious Adverse Events
PTI-125
Affected / at Risk (%) # Events
Total   0/13 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PTI-125
Affected / at Risk (%) # Events
Total   1/13 (7.69%)    
General disorders   
Fall  1 [1]  1/13 (7.69%)  1
Dehydration  1  1/13 (7.69%)  1
Metabolism and nutrition disorders   
B12 deficiency  1  1/13 (7.69%)  1
Musculoskeletal and connective tissue disorders   
Hypercalcemia  1  1/13 (7.69%)  1
Renal and urinary disorders   
Renal colic  1  1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders   
Flu  1  1/13 (7.69%)  1
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
[1]
Moderate severity; rated as unlikely to be related to treatment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Top enrolling PIs are included as authors on Cassava publications, but no individual PI has the right to publish alone without Cassava authorization.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lindsay Burns, SVP of Neuroscience
Organization: Cassava Sciences
Phone: 512-501-2484
EMail: lburns@cassavasciences.com
Layout table for additonal information
Responsible Party: Cassava Sciences, Inc. ( Pain Therapeutics )
ClinicalTrials.gov Identifier: NCT03748706    
Other Study ID Numbers: PTI-125-03
R44AG060878 ( U.S. NIH Grant/Contract )
First Submitted: November 13, 2018
First Posted: November 21, 2018
Results First Submitted: March 3, 2021
Results First Posted: April 1, 2021
Last Update Posted: July 7, 2021