Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
Public ClinicalTrials.gov record NCT06847321. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06847321
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 300 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 55 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 16, 2025
- Primary completion
- Jan 30, 2029
- Completion
- Mar 14, 2029
- Last update posted
- Sep 7, 2026
2025 – 2029
United States locations
- U.S. sites
- 39
- U.S. states
- 20
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner Alzheimer's Institute | Phoenix | Arizona | 85006 | Recruiting |
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | Recruiting |
| Clinical Endpoints | Scottsdale | Arizona | 85258 | Recruiting |
| Oakland Clinical Research | Oakland | California | 94609 | Recruiting |
| ATP Clinical Research, Inc. | Orange | California | 92866 | Recruiting |
| Riverside Clinical Research | Riverside | California | 92506 | Recruiting |
| CenExel Sherman Oaks | Sherman Oaks | California | 91403 | Recruiting |
| CenExel Denver, CO | Englewood | Colorado | 80113 | Recruiting |
| JEM Research Institute | Atlantis | Florida | 33462 | Recruiting |
| Brain Matters Research | Delray Beach | Florida | 33445 | Recruiting |
| Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida | 33912 | Recruiting |
| Conquest Research - Lake Nona | Orlando | Florida | 32832 | Recruiting |
| Anchor Neuroscience | Pensacola | Florida | 32502 | Active, not recruiting |
| Progressive Medical Research | Port Orange | Florida | 32127 | Recruiting |
| Alzheimer's Research and Treatment Center - Stuart | Stuart | Florida | 34997 | Recruiting |
| Alzheimer's Research and Treatment Center - Wellington | Wellington | Florida | 33414 | Recruiting |
| Columbus Memory Center | Columbus | Georgia | 31909 | Recruiting |
| Center for Advanced Research & Education Flourish-Gainesville | Gainsville | Georgia | 30501 | Recruiting |
| Ascension via Christi Research | Wichita | Kansas | 67214 | Recruiting |
| Tandem Clinical Research - Metairie | Metairie | Louisiana | 70006 | Recruiting |
| Headlands PharmaSite | Pikesville | Maryland | 21208 | Recruiting |
| Adams Clinical Boston | Boston | Massachusetts | 02116 | Recruiting |
| Headlands Research-EMA | Plymouth | Massachusetts | 02360 | Recruiting |
| Adams Clinical Watertown | Watertown | Massachusetts | 02472 | Recruiting |
| Neurological Research Center - Hattiesburg Clinic | Hattiesburg | Mississippi | 39401 | Recruiting |
| Clinical Research Professionals - Headlands | Chesterfield | Missouri | 63005 | Recruiting |
| CenExel Research - Toms River | Toms River | New Jersey | 08755 | Recruiting |
| IMA Evaluations | Albuquerque | New Mexico | 87109 | Recruiting |
| Alzheimer's Disease Research Center | Albany | New York | 12208 | Recruiting |
| Adams Clinic Harlem | New York | New York | 10029 | Recruiting |
| Adams Clinical Bronx | The Bronx | New York | 10461 | Active, not recruiting |
| NDx Clinical Research | Dayton | Ohio | 45459 | Recruiting |
| Summitt Research | Portland | Oregon | 97210 | Recruiting |
| K2 Medical Research Nashville LLC | Nashville | Tennessee | 37204 | Recruiting |
| Kerwin Research Center, LLC - Oak Cliff | Dallas | Texas | 75216 | Recruiting |
| Kerwin Research Center, LLC in Texas | Dallas | Texas | 75231 | Recruiting |
| University of Virginia Adult Neurology | Charlottesville | Virginia | 22903 | Recruiting |
| Re-Cognition Health Fairfax | Fairfax | Virginia | 22031 | Recruiting |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06847321, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 7, 2026 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06847321 live on ClinicalTrials.gov.