Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
A Randomized, Double-Blind, Placebo-Controlled Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
1 other identifier
interventional
300
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 alzheimer-disease
Started Feb 2025
Longer than P75 for phase_2 alzheimer-disease
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 17, 2025
CompletedFirst Submitted
Initial submission to the registry
February 21, 2025
CompletedFirst Posted
Study publicly available on registry
February 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 15, 2029
July 31, 2026
June 1, 2026
4 years
February 21, 2025
July 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in ADAS-Cog11
ADAS-COG11 is the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11
40 - 48 weeks
Secondary Outcomes (3)
Change in ADCS-ADL
40 - 48 weeks
Change in CMAI
40 - 48 weeks
Change in CDR-SB
40 - 48 weeks
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo capsule, once daily, for 48 weeks
LHP588 25 mg
EXPERIMENTALOne 25 mg capsule, once daily, for 48 weeks
LHP588 50 mg
EXPERIMENTALTwo 25 mg capsules, once daily, for 48 weeks
Interventions
Eligibility Criteria
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 may not qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
Clinical Endpoints
Scottsdale, Arizona, 85258, United States
Oakland Clinical Research
Oakland, California, 94609, United States
ATP Clinical Research, Inc.
Orange, California, 92866, United States
Riverside Clinical Research
Riverside, California, 92506, United States
CenExel Sherman Oaks
Sherman Oaks, California, 91403, United States
CenExel Denver, CO
Englewood, Colorado, 80113, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
Conquest Research - Lake Nona
Orlando, Florida, 32832, United States
Anchor Neuroscience
Pensacola, Florida, 32502, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Alzheimer's Research and Treatment Center - Stuart
Stuart, Florida, 34997, United States
Alzheimer's Research and Treatment Center - Wellington
Wellington, Florida, 33414, United States
Columbus Memory Center
Columbus, Georgia, 31909, United States
Center for Advanced Research & Education Flourish-Gainesville
Gainsville, Georgia, 30501, United States
Cenexel Savannah GA
Savannah, Georgia, 31405, United States
Ascension via Christi Research
Wichita, Kansas, 67214, United States
Tandem Clinical Research - Metairie
Metairie, Louisiana, 70006, United States
Headlands PharmaSite
Pikesville, Maryland, 21208, United States
Adams Clinical Boston
Boston, Massachusetts, 02116, United States
Headlands Research-EMA
Plymouth, Massachusetts, 02360, United States
Adams Clinical Watertown
Watertown, Massachusetts, 02472, United States
Neurological Research Center - Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Clinical Research Professionals - Headlands
Chesterfield, Missouri, 63005, United States
CenExel Research - Toms River
Toms River, New Jersey, 08755, United States
IMA Evaluations
Albuquerque, New Mexico, 87109, United States
Alzheimer's Disease Research Center
Albany, New York, 12208, United States
Adams Clinic Harlem
New York, New York, 10029, United States
Adams Clinical Bronx
The Bronx, New York, 10461, United States
NDx Clinical Research
Dayton, Ohio, 45459, United States
Summitt Research
Portland, Oregon, 97210, United States
K2 Medical Research Nashville LLC
Nashville, Tennessee, 37204, United States
Kerwin Research Center, LLC - Oak Cliff
Dallas, Texas, 75216, United States
Kerwin Research Center, LLC in Texas
Dallas, Texas, 75231, United States
University of Virginia Adult Neurology
Charlottesville, Virginia, 22903, United States
Re-Cognition Health Fairfax
Fairfax, Virginia, 22031, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stephen Dominy, MD
Lighthouse Pharmaceuticals, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2025
First Posted
February 26, 2025
Study Start
February 17, 2025
Primary Completion (Estimated)
January 31, 2029
Study Completion (Estimated)
March 15, 2029
Last Updated
July 31, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share