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Trial record 40 of 100 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Texas, United States ) | NIH, U.S. Fed

Open-label, PK and Safety Study in Mild-to-moderate Alzheimer's Disease Patients

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ClinicalTrials.gov Identifier: NCT03748706
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Pain Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: PTI-125 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PTI-125
PTI-125 100 mg oral tablets administered twice daily (BID)
Drug: PTI-125
Oral 100 mg tablet




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. Minimum Plasma Concentration (Cmin) [ Time Frame: Study Days 7 and 14 ]
    Assessment of the lowest plasma concentration of PTI-125


Secondary Outcome Measures :
  1. PTI-125DX (biomarker) [ Time Frame: Study Days 1, 7, 14 and 29 ]
    Blood samples will be tested for the companion dignostic/biomarker for Alzheimer's disease.

  2. Biomarker assay [ Time Frame: Day 28 ]
    A CSF sample collection will be performed for Aβ/tau, YKL40 and other potential CSF biomarkers



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages ≥ 50 and ≤ 85 years
  • Informed consent form (ICF) signed by the subject or legally acceptable representative. If a legally acceptable representative signs the ICF, a notation of capacity of the subject must be noted.
  • Clinical diagnosis of dementia due to possible or probable AD consistent with criteria established by a workgroup of the National Institute on Aging and the Alzheimer's Disease Association.
  • MMSE score ≥ 16 and ≤ 24 at screening
  • If female, postmenopausal for at least 1 year
  • Patient living at home, senior residential setting, or an institutional setting without the need for continuous (i.e. 24-h) nursing care
  • General health status acceptable for participation in the study
  • Fluency (oral and written) in English or Spanish
  • If receiving memantine, rivastigmine, galantamine or an AChEI, receiving a stable dose for at least 3 months (90 days) before screening and with continuous dosing for at least 3 months. If receiving donepezil, receiving any dose lower than 23 mg once daily.
  • The patient is a non-smoker for at least 12 months.
  • The patient or legal representative must agree to comply with the drawing of blood samples for the PK assessments, laboratory assessments and PTI-125DX and with a lumbar puncture and the drawing of CSF samples for biomarker assessments.
  • The patient has an Aβ/tau Index in CSF that indicates AD. This value (total tau/Aβ42) will be ≥ 0.30.
  • Patient has a caregiver or legal representative responsible for administering the drug and recording the time.

Exclusion Criteria:

  • Exposure to an experimental drug, experimental biologic or experimental medical device within the longer of 5 half-lives or 3 months before screening
  • Residence in a skilled nursing facility
  • Clinically significant laboratory test results
  • Clinically significant untreated hypothyroidism (if treated, thyroid-stimulating hormone level and thyroid supplementation dose must be stable for at least 6 months before screening)
  • Insufficiently controlled diabetes mellitus or requiring insulin
  • Renal insufficiency (serum creatinine >2.0 mg/dL)
  • Malignant tumor within 3 years before screening (except squamous and basal cell carcinoma or cervical carcinoma in situ or localized prostate cancer or localized stage 1 bladder cancer)
  • History of ischemic colitis or ischemic enterocolitis
  • Unstable medical condition that is clinically significant in the judgment of the investigator
  • Alanine transaminase (ALT) or aspartate transaminase (AST) >2 times the upper limit of normal or total bilirubin greater than the ULN.
  • History of myocardial infarction or unstable angina within 6 months before screening
  • History of more than 1 myocardial infarction within 5 years before screening
  • Clinically significant cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (patients with a pacemaker are acceptable)
  • Symptomatic hypotension, or uncontrolled hypertension
  • Clinically significant abnormality on screening electrocardiogram (ECG), including but not necessarily limited to a confirmed QTc value ≥ 450 msec for males or ≥ 470 msec for females.
  • Stroke within 18 months before screening, or history of a stroke concomitant with onset of dementia
  • History of brain tumor or other clinically significant space-occupying lesion on CT or MRI
  • Head trauma with clinically significant loss of consciousness within 12 months before screening or concurrent with the onset of dementia
  • Onset of dementia secondary to cardiac arrest, surgery with general anesthesia, or resuscitation
  • Specific degenerative CNS disease diagnosis other than AD (eg, Huntington's disease, Creutzfeld-Jacob disease, Down's syndrome, Frontotemporal Dementia, Parkinson's disease)
  • Wernicke's encephalopathy
  • Active acute or chronic CNS infection
  • Donepezil 23 mg or greater QD currently or within 3 months prior to enrollment in the study
  • Discontinued AChEI < 30 days prior to enrollment in the study
  • Antipsychotics; low doses are allowed only if given for sleep disturbances, agitation and/or aggression, and only if the subject has received a stable dose for at least 3 months before enrollment in the study
  • Tricyclic antidepressants and monoamine oxidase inhibitors; all other antidepressants are allowed only if the subject has received a stable dose for at least 3 months before enrollment in the study
  • Anxiolytics or sedative-hypnotics, including barbiturates (unless given in low doses for benign tremor); low doses of benzodiazepines and zolpidem are allowed only if given for insomnia/sleep disturbance, and only if the subject has received a stable dose for at least 3 months before enrollment in the study
  • Peripherally acting drugs with effects on cholinergic transmission
  • Immunosuppressants, including systemic corticosteroids, if taken in clinically immunosuppressive doses (Steroid use for allergy or other inflammation is permitted.)
  • Antiepileptic medications if taken for control of seizures
  • Chronic intake of opioid-containing analgesics
  • Sedating H1 antihistamines
  • Nicotine therapy (all dosage forms including a patch), varenicline (Chantix), or similar therapeutic agent within 30 days before screening
  • Clinically significant illness within 30 days of enrollment
  • History of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease
  • Positive serum hepatitis B surface antigen (HBsAg) or positive hepatitis C virus HCV antibody test at screening
  • Positive HIV test at screening
  • Loss of a significant volume of blood (> 450 mL) within 4 weeks prior to the study
  • Metformin or cimetidine. PTI-125 is a marginal/weak inhibitor of the multidrug and toxin extrusion protein 1 (MATE1) transporter.

Information from the National Library of Medicine

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


Contacts
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Contact: Michael R Marsman, PharmD 5125822173 mmarsman@paintrials.com

Locations
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United States, Texas
Insite Clinical Research Recruiting
DeSoto, Texas, United States, 75115
Contact: Brian Green, MBA    972-331-6898    bgreen@incr.us   
Clinical Trials of Texas Recruiting
San Antonio, Texas, United States, 78229
Contact: Nathan Cortez, MS    210-949-0122 ext 108    ncortez@cttexas.com   
Sponsors and Collaborators
Pain Therapeutics
National Institutes of Health (NIH)

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Responsible Party: Pain Therapeutics
ClinicalTrials.gov Identifier: NCT03748706     History of Changes
Other Study ID Numbers: PTI-125-03
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders