Study of LHP588 for Alzheimer's Disease with P. Gingivalis Infection

This study is testing a drug called LHP588 in people aged 55 to 80 who have mild to moderate Alzheimer's disease (AD) and also have a specific infection called P. gingivalis. P. gingivalis is a type of bacteria that has been linked to dementia. LHP588 is designed to target this bacterium, with the goal of potentially slowing down the progression of AD symptoms. To join, you would need to have AD based on specific criteria, show progressive mental decline, and have P. gingivalis detected in a saliva test. You would also need a blood test showing a certain level of pTau217, a marker for AD. The main way we'll know if LHP588 is working is by measuring changes in your ADAS-Cog11 score, a test of cognitive function, after about 40 to 48 weeks. This study is currently unclear on its recruitment status.

Study design
This is a randomized, double-blind, placebo-controlled study with a planned enrollment of 300 participants. This means participants will be randomly assigned to receive LHP588 (either 25 mg or 50 mg once daily) or a placebo, and neither you nor your doctor will know which you are receiving.
What's involved
Your total participation in the study could last up to 64 weeks, including a screening period of up to 12 weeks, a treatment period of 48 weeks, and a safety follow-up period of 4 weeks. You will need a primary caregiver to assist with your participation and attend clinic visits.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for 4 weeks after the treatment period ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06847321

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

Recruiting
PHASE2Ages 55–80InterventionalTreatment
Lighthouse Pharmaceuticals, Inc.
~300 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:LHP588Placebo Drug

At a glance

Recruiting sites
38 of 40 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in ADAS-Cog11
Measured over 40 - 48 weeks
Alzheimer Disease
Alzheimer Disease Due to P. Gingivalis
40 sites across 20 states
Florida8
California4
Arizona3
Georgia3
Massachusetts3
New York3
Texas2
Virginia2
  • Stephen Dominy, MD · STUDY_DIRECTOR · Lighthouse Pharmaceuticals, Inc.

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
  • Change in ADAS-Cog1140 - 48 weeks

    ADAS-COG11 is the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11