CompletedPhase 1

A Multiple Ascending Dose Study of COR388

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of COR388 in Older Healthy Volunteers and Patients With Alzheimer's Disease

Lead sponsor

Cortexyme Inc.

Asset

COR388

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 14-25•Study partner/caregiver required

Primary endpoints

•AUC•Cmax•Tmax

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCOR388-002

NCT IDNCT03418688

Timeline

Milestones

Study first posted2018-02-01actual

Study start2018-03-06actual

Primary completion2018-10-15actual

Study completion2018-10-15actual

Last update posted2018-11-07actual

Assets

Drug assets

COR388

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Male or female subjects ≥55 years to ≤80 years of age, at the time of consent;

•Males of reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse from the first dose of study drug through 90 days after the last dose of study drug.

•Females of child-bearing potential must be non-lactating, have negative serum pregnancy test results at Screening and negative urine pregnancy test results at Day -1; agree to use double-barrier or hormonal contraceptive measures or avoid intercourse from Day -10 through 28 days after the last dose of study drug.

•Stable doses of medications used for stable chronic illnesses that are not prohibited by the protocol are allowed as long as the dose has been stable for 30 days prior to Screening, and no changes are expected during participation in the study;

•Body mass index ≥19 kg/m2 to ≤35 kg/m2 at Screening;

•Good general health as determined by medical history, physical examination, laboratory reports, and 12-lead ECG prior to enrollment;

•Non-smoker and non-tobacco user for a minimum of 6 months prior to the first admission and for the duration of the study;

•Able to swallow capsules;

•Fluent in, and able to read and comprehend, the English language;

Cohort 4 Only:

•Must have probable AD according to the NINDS-ADRD criteria; and an MMSE-2 score ≥14 and ≤25;

•Must have moderate to severe periodontitis according to the CDC-AAP criteria as determined by the study dentist during the screening oral examination;

•If applicable, have a primary caregiver willing to accept responsibility for supervising the treatment (eg, administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements.

•Provide, if mentally competent and willing, written informed consent. If the subject is not able to provide written informed consent, written informed consent must be obtained from a legally authorized representative on the subject's behalf, and verbal assent may be obtained from the subject. In addition, if the subject has a caregiver, the caregiver will be required to provide written informed consent prior to the subject's participation in the study

Exclusion criteria

•History or current evidence of clinically significant arrhythmia, heart failure, or hypotension in the Investigator's judgment;

•History or current evidence of clinically significant liver disease in the Investigator's judgment;

•Evidence of renal insufficiency defined as an estimated glomerular filtration rate <50 mL/min/1.73m2 at Screening;

•Subjects who received any treatment for periodontitis in the last 90 days including systemic or local antibiotics (eg, PerioChip®), scaling, root planing, or other surgical treatments;

•Uncontrolled medical or psychiatric illness, uncontrolled seizure disorder, or history of major stroke;

•Active, or recent history of, systemic infection within 30 days prior to Screening that required treatment with antibiotics for longer than 1 week;

•History or current evidence of psychiatric or emotional problems that would invalidate giving informed consent or limit the ability of the subject to comply with study requirements;

•History of systemic allergic reaction to any drug that is considered significant by the Investigator;

•History of alcohol or drug abuse or dependence within 12 months of Screening, as determined by the Investigator;

•Positive alcohol screen at Screening or on Day -1;

•Positive urine screen for prohibited drugs

•Positive blood screen for human immunodeficiency virus (1 and 2), hepatitis B surface antigen, or hepatitis C virus antibodies at Screening;

•Any conditions that, in the opinion of the Investigator, would make the subject unsuitable for enrollment, could interfere with the subject's participation in or completion of the study, or could interfere with interpretation of study results;

•Abnormal results of screening laboratory tests, ECG, or MRI of the brain deemed clinically significant by the Investigator;

•The use of any prohibited medication that cannot be stopped or replaced safely, based on the judgment of the Investigator; or

•Participation in another investigational new drug research study involving small molecule drugs within 30 days or biological drugs within 60 days prior to the first dose of study drug.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

AUC

Time frame:Day 1 and Day 10

concentration, descriptive

Primary/protocol endpoint

Cmax

Time frame:Day 1 and Day 10

concentration, descriptive

Primary/protocol endpoint

Tmax

Time frame:Day 1 and Day 10

time to event, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.