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

Launched by LIGHTHOUSE PHARMACEUTICALS, INC. · Feb 21, 2025

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ClinConnect Summary

This clinical trial is studying a new treatment called LHP588 for people with mild to moderate Alzheimer's disease who also have an infection caused by a bacterium known as P. gingivalis. Researchers believe that this bacterium may play a role in the progression of Alzheimer's disease. The goal of the trial is to see if LHP588 can help slow down the decline in mental abilities associated with Alzheimer’s. To participate, individuals must be between 20 and 92 years old, have a certain score on a mental assessment test, and show a positive saliva test for the P. gingivalis infection.

Participants in the trial will take a capsule of LHP588 or a placebo (a pill with no medicine) once a day for up to 48 weeks. The trial will last a total of about 64 weeks, which includes time for screening, treatment, and follow-up health checks. Throughout the trial, participants will need to visit the study center with a caregiver at least 20 times. It's important to know that neither the participant nor their doctor will know whether they are receiving the actual treatment or the placebo. Caregivers will also play a role in the study, helping to support participants during their involvement.

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Eligibility criteria

• Inclusion Criteria:
• • AD according to the National Institute on Aging-Alzheimer's Association criteria.
• • MMSE score between 12 and 24.
• • 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.