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

NCT ID: NCT06847321
Registry status: Recruiting
Study type: Interventional
Phase: Phase 2
Sponsor: Lighthouse Pharmaceuticals, Inc.
Conditions: Alzheimer Disease, Alzheimer Disease Due to P. Gingivalis

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 300 participants (Estimated).

What is being studied

Intervention: Chemical Actions and Uses
Intervention: Contraceptive Agents
Intervention: Contraceptive Agents, Female
Intervention: Contraceptives, Oral
Drug: LHP588
Intervention: Pharmacologic Actions
Intervention: Physiological Effects of Drugs
Drug: Placebo Drug
Intervention: Reproductive Control Agents
Intervention: Therapeutic Uses

Who may be eligible

Ages: 55 Years to 80 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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.

Study locations

39 study locations are listed.

Recruiting site status is explicitly provided for 39 locations; 37 are listed as Recruiting.

Countries: United States

Arizona, United States: 3
California, United States: 5
Colorado, United States: 1
Florida, United States: 8
Georgia, United States: 2
Kansas, United States: 1
Louisiana, United States: 1
Maryland, United States: 1
Massachusetts, United States: 3
Mississippi, United States: 1
Missouri, United States: 1
New Jersey, United States: 1
New Mexico, United States: 1
New York, United States: 2
Ohio, United States: 1
Oregon, United States: 1
Tennessee, United States: 1
Texas, United States: 2
Virginia, United States: 2
Washington, United States: 1

Sample of listed locations

Banner Alzheimer's Institute — Phoenix, Arizona, 85006, United States — Recruiting
Barrow Neurological Institute — Phoenix, Arizona, 85013, United States — Recruiting
Clinical Endpoints — Scottsdale, Arizona, 85258, United States — Recruiting
Oakland Clinical Research — Oakland, California, 94609, United States — Recruiting
ATP Clinical Research, Inc. — Orange, California, 92866, United States — Recruiting
Riverside Clinical Research — Riverside, California, 92506, United States — Recruiting
CenExel Sherman Oaks — Sherman Oaks, California, 91403, United States — Recruiting
CenExel Denver, CO — Englewood, Colorado, 80113, United States — Recruiting
JEM Research Institute — Atlantis, Florida, 33462, United States — Recruiting
Brain Matters Research — Delray Beach, Florida, 33445, United States — Recruiting
Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida, 33912, United States — Recruiting
Conquest Research - Lake Nona — Orlando, Florida, 32832, United States — Recruiting
Progressive Medical Research — Port Orange, Florida, 32127, United States — Recruiting
Alzheimer's Research and Treatment Center - Stuart — Stuart, Florida, 34997, United States — Recruiting
Alzheimer's Research and Treatment Center - Wellington — Wellington, Florida, 33414, United States — Recruiting
Columbus Memory Center — Columbus, Georgia, 31909, United States — Recruiting
Center for Advanced Research & Education Flourish-Gainesville — Gainsville, Georgia, 30501, United States — Recruiting
Ascension via Christi Research — Wichita, Kansas, 67214, United States — Recruiting
Tandem Clinical Research - Metairie — Metairie, Louisiana, 70006, United States — Recruiting
Headlands PharmaSite — Pikesville, Maryland, 21208, United States — Recruiting
Adams Clinical Boston — Boston, Massachusetts, 02116, United States — Recruiting
Headlands Research-EMA — Plymouth, Massachusetts, 02360, United States — Recruiting
Adams Clinical Watertown — Watertown, Massachusetts, 02472, United States — Recruiting
Neurological Research Center - Hattiesburg Clinic — Hattiesburg, Mississippi, 39401, United States — Recruiting
Clinical Research Professionals - Headlands — Chesterfield, Missouri, 63005, United States — Recruiting

Study details

Start date: February 17, 2025
Primary completion date: January 31, 2029
Completion date: March 15, 2029
First posted: February 26, 2025

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06847321
Registry last updated: September 21, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT06847321 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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