Ph 2a study of CY6463 in participants with Alzheimer’s disease and vascular pathology

  • STATUS
    Recruiting
  • days left to enroll
    70
  • participants needed
    30
  • sponsor
    Cyclerion Therapeutics
Updated on 30 March 2022
dementia
mini-mental state examination
alzheimer's disease
mental state examination

Summary

This study is being conducted to evaluate an oral investigational drug called CY6463 in individuals 60 years of age and older who have Alzheimer’s disease (AD) and common cardiovascular risk factors such as high blood pressure, diabetes, high cholesterol, and/or elevated body mass. 

The main goals of this study are to better understand the safety and tolerability of CY6463 and its impact on the brain’s activity in this population.

Treatment: Placebo, CY6463
Posted on clinicaltrials.gov: NCT04798989

Description

CY6463 acts on the nitric oxide signaling pathway in the brain. This pathway is important for many aspects of brain health, including control of blood flow in the brain, how brain cells use energy, and how those cells communicate with one another. Impairment of this pathway is a critical part of the origin of many neurological diseases that can cause a loss of brain function, including memory and decision-making abilities. 

CY6463 may help people with AD and cardiovascular disease maintain or recover some of their original cognitive function due to CY6463’s expected impact on neurons and blood vessels in the brain. 

In addition to evaluating the safety of CY6463, this study will explore whether CY6463 improves blood flow in the brain, diminishes signs of brain degeneration and inflammation, and improves brain function. Cognitive tests will also be conducted to evaluate whether CY6463 improves memory and attention. 

Travel assistance may be available, including transportation to and from the study visits for you and a care partner. 

To learn more, please speak with a member of the study staff.

Study Schedule
Participants will take study drug tablets by mouth each day for about 87 days (~3 months). About half of the participants will be randomized to take CY6463 and the other half will be randomized to take placebo (a pill with no active drug in it). Neither the participants nor the study doctors will know which type of pill each participant is taking.   

Participants will complete 7 scheduled visits over about 5 months, from Screening (up to 60 days) through Follow-up (about 14 days after the last dose), with each visit lasting most of the day. The schedule allows the activities for a given visit to be split across multiple days, if needed.

Study Activities May Include:
Participants will visit their study doctors who will assess their health and disease status and perform tests of brain activity. The brain tests are not invasive, which means they take measurements from outside of the body, and include electroencephalography (or “EEG”), which measures electrical activity of the brain, and magnetic resonance imaging (or “MRI”), which takes pictures of the brain. 

Participants will take study drug tablets by mouth once each day during the treatment period and will be asked to complete a daily diary. 

During each study visit, blood will be collected, vital signs will be measured, and the heart will be checked using an electrocardiogram (or “ECG”). Several questionnaires will also be administered, including a few that assess cognitive function. 

Two samples of cerebral spinal fluid (the clear fluid that surrounds the brain and spinal cord), will be collected: one at the beginning of the study before the first dose of study drug, and the other at the end of the study, after the last dose of study drug.


Details
Condition Alzheimer’s Disease, Alzheimer’s Disease with Vascular Pathology, Mild Cognitive Impairment, Dementia
Clinical Study IdentifierNCT04798989
SponsorCyclerion Therapeutics
Last Modified on30 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Provide written informed consent prior to the performance of any protocol-specified procedure or, if unable to provide informed consent due to cognitive status, provide assent to participate, with a legally authorized representative (LAR) providing written informed consent on behalf of the participant
years of age or older
Meet 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
MRI (existing MRI obtained up to 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, agree to refrain from donating sperm from the Screening visit through 90 days after taking the final study drug dose
If male, agree to use protocol specified, effective contraception methods from the signing of the ICF until 90 days after taking the final study drug dose
If female, is postmenopausal/not of reproductive potential defined per protocol
Agree to the study procedures, including undergoing lumbar puncture for CSF samples

Exclusion Criteria

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 CNS trauma that has affected brain function
Low blood pressure, 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 other than 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
Additional inclusion and exclusion criteria may apply per protocol
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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