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

NCT04798989 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: C6463-202
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 5

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 Alzheimer's disease (AD) along with common cardiovascular risk factors.

Conditions

Alzheimer's Disease With Vascular Pathology

Keywords

Alzheimer's disease; AD; ADv; CY6463; Subcortical small-vessel disease; Elderly; 60 and older; Probable AD dementia; Vascular dementia; Mixed dementia

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-emergent Adverse Events (TEAEs) From Study Drug Initiation Through Follow-up

  TEAE is defined as an adverse event with an onset that occurs after receiving the study drug, until the end of the Follow-up period

  From first dose of study treatment through ~14 (±4) days after the final dose

Study Arms (2)

CY6463

EXPERIMENTAL

CY6463 once daily (QD) for approximately 87 sequential days.

Drug: CY6463

Placebo

PLACEBO COMPARATOR

Placebo QD for approximately 87 sequential days.

Drug: Placebo

Interventions

CY6463 DRUG

CY6463 Oral Tablet

Also known as: IW-6463, zagociguat

CY6463

Placebo DRUG

Placebo Oral Tablet

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tisento Therapeutics: lead

Study Sites (5)

Clinical Endpoints

Scottsdale, Arizona, 85258, United States

Location

Optimus U Corp

Miami, Florida, 33125, United States

Location

Hawaii Pacific Neurosciences, LLC

Honolulu, Hawaii, 96817, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia, Vascular; Mixed Dementias

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Clinical Research
• Organization: Tisento Therapeutics

hello@tisentotx.com

1-857-259-5371

Study Officials

• Study Director

  Tisento Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: November 2, 2021
• Primary Completion: November 28, 2022
• Study Completion: November 28, 2022
• Last Updated: October 30, 2024
• Results First Posted: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)