Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease (NCT06847321)
A Randomized, Double-Blind, Placebo-Controlled Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Banner Alzheimer's Institute — Phoenix, Arizona
Age range: 55 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (40 Sites)
Showing the first 25 of 40 sites.
- Banner Alzheimer's Institute — Phoenix, Arizona
- Barrow Neurological Institute — Phoenix, Arizona
- Clinical Endpoints — Scottsdale, Arizona
- Oakland Clinical Research — Oakland, California
- ATP Clinical Research, Inc. — Orange, California
- Riverside Clinical Research — Riverside, California
- CenExel Sherman Oaks — Sherman Oaks, California
- CenExel Denver, CO — Englewood, Colorado
- JEM Research Institute — Atlantis, Florida
- Brain Matters Research — Delray Beach, Florida
- Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida
- Conquest Research - Lake Nona — Orlando, Florida
- Anchor Neuroscience — Pensacola, Florida
- Progressive Medical Research — Port Orange, Florida
- Alzheimer's Research and Treatment Center - Stuart — Stuart, Florida
- Alzheimer's Research and Treatment Center - Wellington — Wellington, Florida
- Columbus Memory Center — Columbus, Georgia
- Center for Advanced Research & Education Flourish-Gainesville — Gainsville, Georgia
- Cenexel Savannah GA — Savannah, Georgia
- Ascension via Christi Research — Wichita, Kansas
- Tandem Clinical Research - Metairie — Metairie, Louisiana
- Headlands PharmaSite — Pikesville, Maryland
- Adams Clinical Boston — Boston, Massachusetts
- Headlands Research-EMA — Plymouth, Massachusetts
- Adams Clinical Watertown — Watertown, Massachusetts
📞 Contact the Study Coordinator
Phone: (858) 248-5124
Email: jbolger@lighthousepharma.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.