NCT06847321 · Phase 2 · RECRUITING
Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
This Phase 2 trial is testing LHP588, an oral capsule taken once daily, in people with mild to moderate Alzheimer's disease who also test positive for P. gingivalis — a gum bacterium linked to dementia risk. The goal is to see whether targeting this infection can slow cognitive decline, measured by standard memory tests and a blood biomarker called pTau217. Phase 2 means researchers are still building evidence on whether it works and is safe.
You may qualify if
- 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.
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-06-24