Skip to main content
Delfa

← Trials/Trial dossier/NCT06847321

RecruitingPhase 2

Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease

A Randomized, Double-Blind, Placebo-Controlled Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease

Asset

LHP588

Listed sites

39

Recruiting sites

39

Enrollment

300

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Age 55-80

Primary endpoint

•ADAS-Cog

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 IDLHP588-201
NCT IDNCT06847321

Timeline

Milestones

Study start2025-02-17actual
Study first posted2025-02-26actual
Last update posted2026-07-14actual
Primary completion2029-01-31estimated
Study completion2029-03-15estimated

Assets

Drug assets

LHP588

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•AD according to the National Institute on Aging-Alzheimer's Association criteria.
•MMSE scores corresponding to mild and moderate AD.
•Saliva rinse sample positive for P. gingivalis.
•Plasma pTau217 above cutoff.
•Subject and caregiver have provided full written informed consent.
•Background symptomatic therapy with acetylcholinesterase inhibitors, and/or memantine, are allowed if the dose has been stable for 90 days and no changes are planned during the study.
•Modified Hachinski score ≤4 at screening

Exclusion criteria

•History of cancer requiring systemic therapy in last 5 years.
•Evidence of a clinically significant, unstable cardiovascular, pulmonary, renal, hepatic, gastrointestinal, neurologic, or metabolic disease within 6 months prior to screening.
•Unstable angina, uncompensated and/or symptomatic congestive heart failure (Grade 2 or higher on the New York Heart Association scale) or myocardial infarction within 6 months.
•Acute or poorly controlled blood pressure >180 mmHg systolic or >100 mmHg diastolic at screening visit.
•History or current evidence of major neurological or psychiatric illness such as schizophrenia, bipolar disorder, Parkinson's Disease, other.
•Currently being treated with anti-amyloid beta antibodies or other disease-modifying treatments for dementia.
•Other criteria in the Investigator's judgement that may interfere with the ability to participate in the study.

Endpoints (4)

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.

Coverage by outcome category

Global cognition
1
Function / daily living
1
Behavior / neuropsychiatric
1
Other (unclassified)
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Change in CDR-SB

Time frame:40 - 48 weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

Change in ADCS-ADL

Time frame:40 - 48 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Change in CMAI

Time frame:40 - 48 weeks

change from baseline, improvement

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Change in ADAS-Cog11

Time frame:40 - 48 weeks

ADAS-Cog

change from baseline, improvement

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.