NCT06847321 Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
| NCT ID | NCT06847321 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Lighthouse Pharmaceuticals, Inc. |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-02-17 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 300 participants in total. It began in 2025-02-17 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is to test LHP588 in persons who have mild to moderate Alzheimer's disease (AD) who have shown progressive mental decline in the last year and who have P. gingivalis (Pg) infection. P. gingivalis infection has been linked to the development of dementia. LHP588 is designed to target the P. gingivalis bacterium, to potentially help to halt or slow down the progression of AD and its symptoms. A saliva test will be done to determine P. gingivalis infection. Tests for AD include standard questionnaires such as MMSE and a blood test for pTau217. Treatment will be blinded, meaning the participant and the doctor will not know if the participant is receiving LHP588 or placebo. The total time for participation in the study may be up to 64 weeks. This includes a screening period (to ensure the participant is suitable for the study and the study is suitable for the participant) of up to 12 weeks, a treatment period of up to 48 weeks, and a safety follow-up period of 4 weeks after the last dose of the study drug to check the participant's overall health. Treatment is a once-a-day capsule. Caregiver participation is required. The study requires the participant to visit the study center (with the caregiver) at least 20 times within 64 weeks (this does not include any unplanned visits that may be recommended by the study doctor). In addition, the study doctor or clinic staff will contact the participant via phone at least 1 time.
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.
Contact & Investigator
Stephen Dominy, MD
STUDY DIRECTOR
Lighthouse Pharmaceuticals, Inc.
Frequently Asked Questions
Who can join the NCT06847321 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 80 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06847321 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06847321 currently recruiting?
Yes, NCT06847321 is actively recruiting participants. Contact the research team at jbolger@lighthousepharma.com for enrollment information.
Where is the NCT06847321 trial being conducted?
This trial is being conducted at Phoenix, United States, Phoenix, United States, Scottsdale, United States, Oakland, United States and 11 additional locations.
Who is sponsoring the NCT06847321 clinical trial?
NCT06847321 is sponsored by Lighthouse Pharmaceuticals, Inc.. The principal investigator is Stephen Dominy, MD at Lighthouse Pharmaceuticals, Inc.. The trial plans to enroll 300 participants.
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