Phase 1 Alzheimer's Disease Trial, Not Yet Recruiting NCT07568041 Sponsor: Cenna Biosciences Inc. Condition: Alzheimer's Disease
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Phase 1 Alzheimer's Disease Trial, Not Yet Recruiting

NCT07568041
Not Yet Recruiting Phase 1

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

Parts I and II (Healthy Volunteer Sections):

  • People who voluntarily agree to take part and sign a written consent form before any trial activities begin.
  • Healthy men and women between 18 and 55 years of age (inclusive).
  • People whose body mass index (BMI) falls between 18 and 32 (inclusive) and who weigh at least 50 kg.
  • People whose heart tracing test (ECG) comes back normal at the screening visit.
  • People whose kidneys are functioning normally.
  • Female participants must either be unable to become pregnant naturally, or if pregnancy is possible, must agree to use contraception throughout the study and have a negative pregnancy test at both the screening visit and the day before dosing begins.
  • Male participants whose female partner could become pregnant must either have had a sterilisation procedure, agree to use condoms with spermicide, or abstain from sex from the screening visit until 90 days after the last dose of trial medication.
  • People who are willing and able to complete all trial activities, stay in the inpatient unit for the full required period, and return for all follow-up visits.

Part III (Alzheimer's Disease Section):

  • People who are able to provide written consent before any trial-specific procedures take place.
  • Men or women with early Alzheimer's disease between 55 and 80 years of age (inclusive), who the investigating doctor considers to be in good general health.
  • People whose BMI falls between 18 and 32 (inclusive) and who weigh at least 50 kg.
  • People whose heart tracing test (ECG) at screening shows no abnormalities that the investigating doctor considers to be a safety concern.
  • Female participants must either be unable to become pregnant naturally, or if pregnancy is possible, must agree to use contraception throughout the study and have a negative pregnancy test at both the screening visit and the day before dosing begins.
  • Male participants whose female partner could become pregnant must either have had a sterilisation procedure, agree to use condoms with spermicide, or abstain from sex from the screening visit until 90 days after the last dose of trial medication.
  • People who are willing and able to complete all trial activities, stay in the inpatient unit for the full required period, and return for all follow-up visits.
  • People who meet the established diagnostic criteria for mild cognitive impairment due to probable Alzheimer's disease, as defined by the National Institute on Aging – Alzheimer's Association research framework.
  • People with a qualifying amyloid score (confirm with trial site for specific threshold).
  • People who score between 20 and 28 (inclusive) on the Mini-Mental State Examination (a standard memory and thinking test) at both the screening visit and the start of the trial.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

Parts I and II (Healthy Volunteer Sections):

  • People with a significant history or current condition affecting the heart, lungs, liver, kidneys, blood, digestive system, hormones, immune system, skin, nervous system, or mental health, or any other condition the investigating doctor considers a safety risk.
  • People whose blood or urine test results at screening or on the day before dosing suggest a significant underlying health condition.
  • People who show signs of suicidal thoughts as assessed by a standard screening tool at the screening visit or the day before dosing, or who have a history of a suicide attempt at any point in their life.
  • People who test positive for Hepatitis B, Hepatitis C, or HIV at screening.
  • People who have smoked cigarettes or used other nicotine-containing products in the three months before screening.
  • People who have regularly consumed alcohol in the six months before the trial, defined as more than 20 units per week for men or more than 16 units per week for women (where one unit equals 8g of ethanol).
  • People who test positive for alcohol, nicotine, or drugs of abuse in a urine test at screening or on the day before dosing begins.
  • People with a history of drug abuse (as defined by standard psychiatric diagnostic criteria) within the two years before entering the study.
  • People who have taken part in another clinical trial or received an investigational medicine within 90 days before the first dose of the trial medication.
  • People who have lost 500 mL or more of blood (roughly one unit) within 90 days before the first dose of the trial medication.
  • People whom the investigating doctor considers unsuitable for the trial for any other reason.

Part III (Alzheimer's Disease Section):

  • People with a history or current presence of any uncontrolled systemic disease, such as high blood pressure (systolic at or above 150 mmHg or diastolic at or above 100 mmHg) or diabetes with an HbA1c level at or above 8% at screening.
  • People with a history or current presence of unstable or significant heart, kidney, or liver disease (for example, a previous heart attack).
  • People with any active or unstable significant medical or psychiatric condition, as determined by the investigating doctor.
  • People with serious or unstable illnesses affecting the liver, kidneys, digestive system, breathing, heart, hormones, nervous system (other than Alzheimer's disease), immune system, or blood, or any other condition the investigating doctor believes could interfere with assessing the trial's safety or effectiveness.
  • People who have evidence of a condition other than Alzheimer's disease that may affect thinking and memory, such as other forms of dementia, stroke, brain injury, autoimmune conditions (such as multiple sclerosis), or infections that have affected the nervous system.
  • People with a history of a primary or returning cancer within the past five years, with the exception of certain treated skin cancers, treated cervical cancer in situ, or treated prostate cancer in situ with a normal result on a specific marker test after treatment.
  • People with a history of bleeding in the brain, a brain aneurysm, abnormal blood vessels in the brain, blocked carotid artery, stroke, or epilepsy.
  • People who show signs of suicidal thoughts as assessed by a standard screening tool at the screening visit or the day before dosing, or who have a history of a suicide attempt at any point in their life.
  • People who test positive for Hepatitis B, Hepatitis C, or HIV at screening.

Important: Always verify eligibility with the trial site directly before applying."

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 31 July 2026

If you need support right now

This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.

If you or someone else is in immediate danger, call 000.

  • Lifeline — 24/7 crisis support: 13 11 14
  • Suicide Call Back Service — 24/7 counselling: 1300 659 467
  • 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
  • Beyond Blue — 24/7 mental health support: 1300 22 4636
  • Emergency: 000

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.

Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

Contact this trial

Principal Investigator: Nazneen Dewji, PhD, Cenna Biosciences

Phone: 619-912-7475

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Phase 1
Sponsor
Cenna Biosciences Inc.
Registry
ClinicalTrials.gov
Start date
15 September 2026
Est. completion
1 September 2027

Primary endpoints

Number of participants reporting treatment-emergent adverse events; Number of participants reporting treatment-emergent adverse events that require discontinuation of therapy due to intolerable side effects; Number of participants reporting injection site reactions; Number of participants demonstrating abnormal laboratory findings; Number of participants demonstrating abnormal vital signs; Number of participants demonstrating abnormal vital electrocardiogram (ECG) parameters; Number of participants demonstrating adverse changes in physical and/or neurologic examinations; Number of participants...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov