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Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
Sponsor: Lighthouse Pharmaceuticals, Inc.
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 pTau 217. 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.
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
Key Details
Gender
All
Age Range
55 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-02-17
Completion Date
2028-12
Last Updated
2026-05-18
Healthy Volunteers
No
Interventions
LHP588
25 mg, once dialy
LHP588
50 mg, once daily
Placebo Drug
Placebo, once daily
Locations (39)
Banner Alzheimer's Institute
Phoenix, Arizona, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
Clinical Endpoints
Scottsdale, Arizona, United States
Oakland Clinical Research
Oakland, California, United States
ATP Clinical Research, Inc.
Orange, California, United States
Riverside Clinical Research
Riverside, California, United States
CenExel Denver, CO
Englewood, Colorado, United States
JEM Research Institute
Atlantis, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
Conquest Research - Lake Nona
Orlando, Florida, United States
Anchor Neuroscience
Pensacola, Florida, United States
Alzheimer's Research and Treatment Center - Stuart
Stuart, Florida, United States
Alzheimer's Research and Treatment Center - Wellington
Wellington, Florida, United States
Columbus Memory Center
Columbus, Georgia, United States
Center for Advanced Research & Education Flourish-Gainesville
Gainsville, Georgia, United States
Cenexel Savannah GA
Savannah, Georgia, United States
Ascension via Christi Research
Wichita, Kansas, United States
Tandem Clinical Research - Metairie
Metairie, Louisiana, United States
Headlands PharmaSite
Pikesville, Maryland, United States
Adams Clinical Boston
Boston, Massachusetts, United States
Headlands Research-EMA
Plymouth, Massachusetts, United States
Adams Clinical Watertown
Watertown, Massachusetts, United States
Neurological Research Center - Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Clinical Research Professionals - Headlands
Chesterfield, Missouri, United States
CenExel Research - Toms River
Toms River, New Jersey, United States
IMA Evaluations
Albuquerque, New Mexico, United States
Alzheimer's Disease Research Center
Albany, New York, United States
Adams Clinic Harlem
New York, New York, United States
Adams Clinical Bronx
The Bronx, New York, United States
NDx Clinical Research
Dayton, Ohio, United States
Summitt Research
Portland, Oregon, United States
K2 Medical Research Nashville LLC
Nashville, Tennessee, United States
Kerwin Research Center, LLC - Oak Cliff
Dallas, Texas, United States
Kerwin Research Center, LLC in Texas
Dallas, Texas, United States
Re:Cognition Health - Houston
Houston, Texas, United States
University of Virginia Adult Neurology
Charlottesville, Virginia, United States
Re-Cognition Health Fairfax
Fairfax, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States