RecruitingPhase 2NCT06847321

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

Sponsor

Lighthouse Pharmaceuticals, Inc.

Enrollment

300 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease Alzheimer Disease Due to P. Gingivalis

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.

Eligibility

Min Age: 55 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called LHP588 for people with Alzheimer's disease whose saliva tests positive for a bacterium called Porphyromonas gingivalis (a gum disease bacteria that has been found in Alzheimer's brain tissue). The study investigates whether treating this bacterial infection could slow cognitive decline. **You may be eligible if...** - You have a diagnosis of Alzheimer's disease - Your score on a standard memory test (MMSE) is between 12 and 24 (mild to moderate range) - Your saliva tests positive for P. gingivalis bacteria - Your blood test shows elevated pTau217 (a marker of Alzheimer's) - You have a caregiver who can participate with you and provide consent - You are on a stable Alzheimer's background medication (if applicable) **You may NOT be eligible if...** - Your saliva tests negative for P. gingivalis - Your memory test score is outside the 12–24 range - You lack a caregiver able to consent and participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLHP588

25 mg, once dialy

DRUGLHP588

50 mg, once daily

DRUGPlacebo Drug

Placebo, once daily

Locations(35)

Banner Alzheimer's Institute

Phoenix, Arizona, United States

Barrow Neurological Institute

Phoenix, Arizona, United States

Clinical Endpoints

Scottsdale, Arizona, United States

ATP Clinical Research, Inc.

Orange, California, 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

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

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NCT06847321

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