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Safety and Pharmacokinetics of ALZ-507 in Healthy Elderly Adults

A Phase 1, Single-Center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics in Plasma, Urine and CSF of Single and Multiple Ascending Doses of ALZ-507 in Healthy Participants

Who can join

Ages 50 to 75 · All sexes · Healthy volunteers welcome

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

About the study

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.

What is being tested

• ALZ-507 (drug)
• Placebo (drug)

Sponsor: Alzheon Inc. · Participants: 84 · Started: Mar 9, 2026

Contact the study team

• John Hey, PhD · Phone: 508.861.7709

Official record on ClinicalTrials.gov — NCT07824271

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.