Recruiting
Phase 1

ALZ-507

Sponsor:

Alzheon Inc.

Code:

NCT07824271

Conditions

Healthy Participants Study

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

ALZ-507

Placebo

Study Details

Brief summary:

Researchers are testing an investigational medicine called ALZ-507 in healthy adults between 50 and 75 years of age.

The purpose of this study is to learn:

Assess if oral ALZ-507 is safe What side effects may occur How the body absorbs ALZ-507 Whether food affects how ALZ-507 is absorbed How much ALZ-507 reaches the blood, cerebrospinal fluid, and urine

Participants will receive either ALZ-507 or a placebo. Some participants will receive a single dose, while others will receive daily doses for two weeks. Researchers will monitor participants closely through medical examinations, laboratory testing, and collection of blood, cerebrospinal fluid and urine.

The findings from this study will help guide the future development of ALZ-507.

The information from this study will help determine whether ALZ-507 is safe for further clinical development.

Conditions

Healthy Participants Study

Study ID

NCT07824271

Start date

Mar 9, 2026

Status verified date

Sep, 2026

Completion date

Nov 9, 2026

Anticipated

Primary completion date

Oct 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy males and females aged 50 to 75 years, inclusive
  • Body mass index 18.0 to 35.0 kg/m2, inclusive, and >50 kg body weight
  • No clinically significant values for vital signs (systolic blood pressure \[BP\] 90 to 140 mmHg, diastolic BP 40 to 90 mmHg, and HR 50 to 100 bpm) and no clinically significant ECG readings, as determined by the principal investigator or sub investigator

Exclusion Criteria:

  • Participation in a clinical research study within the previous 30 days or within a period of less than 5 times the drug's half-life
  • Have previously participated in a trial with ALZ-801 or tramiprosate and received study drug
  • History of any drug or alcohol abuse in the past 2 years
  • Creatinine clearance of <60 mL/min using the Cockcroft-Gault equation at screening
  • Clinically significant abnormal biochemistry, hematology or urinalysis as judged by the investigator
  • History of clinically significant cardiovascular, pulmonary, chronic respiratory, renal, hepatic, GI, immunologic, endocrine, neurologic, psychiatric or thromboembolic disease; a history of metabolic disturbances; or any current physical conditions that could interfere with the interpretation of the study results as judged by the investigator

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo-Controlled

experimental: Experimental Arm

Interventions

ALZ-507

Participants will receive ALZ-507 oral capsules administered as single ascending doses in Part 1 or once daily for 14 days as multiple ascending doses in Part 2

Placebo

Matching placebo capsules administered orally according to the same dosing schedule as ALZ-507

Primary outcome measure

  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Following Single Ascending Doses of ALZ-507 [ Time Frame: From first dose through the follow-up visit (up to approximately 31 days in Part 1 and up to approximately 35 days in Part 2). ]

Central Contacts and Locations

Central contacts

John Hey, PhD

508.861.7709john.hey@alzheon.com

Locations

Quotient Sciences

Recruiting

Miami, Florida, United States, 33126

Contacts

Laura Gonzalez

305-644-9903Laura.Gonzalez@quotientsciences.com

More Information

Sponsor

Alzheon Inc.

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Alzheon Inc. on 2026-09-17.