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Status:

TERMINATED

A Study of the Effects of CY6463 in Participants With Alzheimer's Disease With Vascular Pathology

Lead Sponsor:

Tisento Therapeutics

Conditions:

Alzheimer's Disease With Vascular Pathology

Eligibility:

All Genders

60+ years

Phase:

PHASE2

Brief Summary

This study is being conducted to test the safety, tolerability, and pharmacokinetics of the investigational drug CY6463 compared with placebo in individuals who are aged 60 years or older and have Alz...

Detailed Description

CY6463 is an investigational drug being developed as a symptomatic and potentially disease-modifying therapy for Alzheimer's disease (AD) and other serious central nervous system disorders. As a solub...

Eligibility Criteria

Inclusion

  • Provide written informed consent prior to the performance of any protocol-specified procedure or, if unable to provide informed consent due to cognitive status, provides assent to participate, with a legally authorized representative (LAR) providing written informed consent on behalf of the participant.
  • 60 years of age or older
  • Meets core clinical criteria for probable AD dementia according to the 2011 National Institute on Aging-Alzheimer's Associated guidelines. Can be based on medical history.
  • Mini-Mental State Examination (MMSE) score of 20 to 26 (inclusive)
  • Confirmation of AD pathophysiology
  • At least 2 cardiovascular risk factors per protocol criteria
  • Magnetic resonance imaging (MRI) scan (existing MRI obtained ≤6 months before Screening is acceptable) findings of mild-to-moderate subcortical small-vessel disease
  • If receiving concomitant or chronic medication(s), has had no change for ≥4 weeks before study drug initiation and has no plans to alter the regimen(s) during the study
  • If male, agrees to refrain from donating sperm from the Screening visit through 90 days after taking the final study drug dose
  • If male, agrees to use protocol-specified, effective contraception methods from the signing of the informed consent form (ICF) until ≥90 days after taking the final study drug dose.
  • If female, is postmenopausal/not of reproductive potential defined per protocol
  • Agrees to the study procedures, including undergoing lumbar puncture for cerebrospinal fluid (CSF) samples

Exclusion

  • Severe visual, auditory, social, or cognitive impairment
  • Dementia-related disorder other than AD or vascular dementia (eg, Parkinson's disease, Huntington's disease, frontotemporal dementia, schizophrenia, Lewy body dementia)
  • Symptomatic large-vessel disease, symptomatic carotid artery disease, large vessel infarcts, or strategic lacunar infarcts or infarcts\>15 mm
  • History of significant central nervous system (CNS) trauma that has affected brain function
  • Low blood pressure (BP), defined as systolic BP ≤90 mmHg or diastolic BP ≤60 mmHg.
  • Orthostatic hypotension.
  • Unable to undergo MRI
  • Unable to undergo lumbar puncture procedure
  • Unable to participate in electroencephalography (EEG) protocol due to hearing impairment or inability to tolerate EEG cap or headphones
  • Uncontrolled or unstable chronic disease
  • Kidney impairment requiring dialysis; history of renal transplant
  • Needs continuous direct medical care and nursing supervision.
  • Family history of short QT syndrome or long QT syndrome
  • Clinically significant cardiac involvement
  • History of cancer. Exceptions: localized cutaneous basal or squamous cell carcinoma in the last 5 years, low-grade localized prostate/cervical cancers, or previous localized prostate/cervical cancers that have a low likelihood of recurrence
  • Is not suited for study participation in the clinical judgment of the investigator
  • Additional inclusion and exclusion criteria apply, per protocol.

Key Trial Info

Start Date :

November 2 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 28 2022

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT04798989

Start Date

November 2 2021

End Date

November 28 2022

Last Update

October 30 2024

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Clinical Endpoints

Scottsdale, Arizona, United States, 85258

2

Optimus U Corp

Miami, Florida, United States, 33125

3

Hawaii Pacific Neurosciences, LLC

Honolulu, Hawaii, United States, 96817

4

University of Kentucky

Lexington, Kentucky, United States, 40536