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

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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 65 years or older and have Alzheimer's disease (AD) along with common cardiovascular risk factors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cyclerion Therapeutics

Criteria

Inclusion Criteria:

1. Provide written informed consent prior 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.

2. 65 years of age or older

3. 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.

4. Mini-Mental State Examination (MMSE) score of 20 to 26 (inclusive)

5. Confirmation of AD pathophysiology

6. At least 2 cardiovascular risk factors per protocol criteria

7. Magnetic resonance imaging (MRI) scan (existing MRI obtained ≤3 months before Screening is acceptable) findings of mild-to-moderate subcortical small-vessel disease

8. 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

9. If male, agrees to refrain from donating sperm from the Screening visit through 90 days after taking the final study drug dose

10. 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.

11. If female, is postmenopausal/not of reproductive potential defined per protocol

12. Agrees to the study procedures, including undergoing lumbar puncture for cerebrospinal fluid (CSF) samples

Exclusion Criteria:

1. Severe visual, auditory, social, or cognitive impairment

2. Dementia-related disorder other than AD or vascular dementia (eg, Parkinson's disease, Huntington's disease, frontotemporal dementia, schizophrenia, Lewy body dementia)

3. Symptomatic large-vessel disease, symptomatic carotid artery disease, large vessel infarcts, or strategic lacunar infarcts or infarcts>15 mm

4. History of significant central nervous system (CNS) trauma that has affected brain function

5. Low blood pressure (BP), defined as systolic BP ≤90 mmHg or diastolic BP ≤60 mmHg.

6. Orthostatic hypotension.

7. Unable to undergo MRI

8. Unable to undergo lumbar puncture procedure

9. Unable to participate in electroencephalography (EEG) protocol due to hearing impairment or inability to tolerate EEG cap or headphones

10. Uncontrolled or unstable chronic disease

11. Kidney impairment requiring dialysis; history of renal transplant

12. Needs continuous direct medical care and nursing supervision.

13. Family history of short QT syndrome or long QT syndrome

14. Clinically significant cardiac involvement

15. History of cancer other than basal cell carcinoma in the last 5 years

Additional inclusion and exclusion criteria apply, per protocol.