Phase
Condition
N/ATreatment
Placebo
CY6463
Clinical Study ID
Ages > 60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provide written informed consent prior to the performance of any protocol-specifiedprocedure 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 NationalInstitute on Aging-Alzheimer's Associated guidelines. Can be based on medicalhistory.
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 beforeScreening is acceptable) findings of mild-to-moderate subcortical small-vesseldisease
If receiving concomitant or chronic medication(s), has had no change for ≥4 weeksbefore study drug initiation and has no plans to alter the regimen(s) during thestudy
If male, agrees to refrain from donating sperm from the Screening visit through 90days after taking the final study drug dose
If male, agrees to use protocol-specified, effective contraception methods from thesigning of the informed consent form (ICF) until ≥90 days after taking the finalstudy drug dose.
If female, is postmenopausal/not of reproductive potential defined per protocol
Agrees to the study procedures, including undergoing lumbar puncture forcerebrospinal fluid (CSF) samples
Exclusion
Exclusion Criteria:
Severe visual, auditory, social, or cognitive impairment
Dementia-related disorder other than AD or vascular dementia (eg, Parkinson'sdisease, Huntington's disease, frontotemporal dementia, schizophrenia, Lewy bodydementia)
Symptomatic large-vessel disease, symptomatic carotid artery disease, large vesselinfarcts, or strategic lacunar infarcts or infarcts>15 mm
History of significant central nervous system (CNS) trauma that has affected brainfunction
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 hearingimpairment 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 carcinomain the last 5 years, low-grade localized prostate/cervical cancers, or previouslocalized 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.
Study Design
Study Description
Connect with a study center
Clinical Endpoints
Scottsdale, Arizona 85258
United StatesSite Not Available
Optimus U Corp
Miami, Florida 33125
United StatesSite Not Available
Synexus Clinical Research US, Inc. - The Villages
The Villages, Florida 32162
United StatesSite Not Available
Hawaii Pacific Neurosciences, LLC
Honolulu, Hawaii 96817
United StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40536
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available

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