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Testing LHP588 for Alzheimer's Disease linked to P. gingivalis infection

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

Phase 2 Interventional Lighthouse Pharmaceuticals, Inc. · NCT06847321

This study is testing if a new treatment called LHP588 can help people with mild to moderate Alzheimer's disease who also have a P. gingivalis infection.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment300 (estimated)
Ages55 Years to 80 Years
SexAll
SponsorLighthouse Pharmaceuticals, Inc. Industry-sponsored
Locations35 sites (Phoenix, Arizona and 34 other locations)
Trial IDNCT06847321 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of LHP588 in individuals with mild to moderate Alzheimer's disease who also have a P. gingivalis infection. Participants will undergo a screening process that includes cognitive assessments and saliva tests to confirm the presence of the bacterium. The study is randomized and double-blind, meaning neither the participants nor the researchers will know who receives the treatment or placebo. The total duration of participation may last up to 64 weeks, including screening, treatment, and follow-up periods.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with mild to moderate Alzheimer's disease and confirmed P. gingivalis infection.

Not a fit: Patients without P. gingivalis infection or those with other forms of dementia may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could potentially slow down the progression of Alzheimer's disease in patients with P. gingivalis infection.

How similar studies have performed: While the approach of targeting P. gingivalis in Alzheimer's disease is innovative, similar studies have shown promise in exploring the link between infections and cognitive decline.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Phoenix, Arizona and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alzheimer DiseaseAlzheimer Disease Due to P. Gingivalisplacebo-controlledp. gingivalisAlzheimer disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.