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RecruitingPhase 2

Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease

Lighthouse Pharmaceuticals, Inc. · NCT06847321

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 55–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
300
US sites recruiting
37
Study start
February 17, 2025
Record last updated
October 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: LHP588; LHP588; Placebo Drug

Conditions: Alzheimer Disease; Alzheimer Disease Due to P. Gingivalis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Recruiting US locations

  • Banner Alzheimer's Institute

    Phoenix, AZ 85006

    Site contact: Laura Martinez, SCRC · 602-839-6500 · BannerAlzResearch@bannerhealth.com

  • Barrow Neurological Institute

    Phoenix, AZ 85013

    Site contact: Margeaux Snell, MD, CCRC · 602-406-3378 · Margeaux.snell@commonspirit.org

  • Clinical Endpoints

    Scottsdale, AZ 85258

    Site contact: Jenna Leger · 480-566-9090 · jleger@clinicalendpoints.com

  • Esperanza Clinical

    Murrieta, CA 92562

    Site contact: Antonio Mason-Villeda · 951-417-4466 · hello@esperanzaclinical.com

  • Oakland Clinical Research

    Oakland, CA 94609

    Site contact: Crystal Huynh · 510-817-2000 · crystal@irvineclinical.com

  • ATP Clinical Research, Inc.

    Orange, CA 92866

    Site contact: Christine Som · 714-662-9556 · christines@pnsoc.com

  • Riverside Clinical Research

    Riverside, CA 92506

    Site contact: Erick Delgado · 951-374-8000 · edelgado@irvineclinical.com

  • CenExel Sherman Oaks

    Sherman Oaks, CA 91403

    Site contact: Mekaela Theobald · (818) 990-2671 · m.theobald@cenexel.com

  • CenExel Denver, CO

    Englewood, CO 80113

    Site contact: Susan McPhie · 720-477-7899 · rmcr.recruitment@cenexel.com

  • JEM Research Institute

    Atlantis, FL 33462

    Site contact: Linda Pao, MD · 561-968-2933 · jem.research@jemri.net

  • Brain Matters Research

    Delray Beach, FL 33445

    Site contact: Jen Blasi · 561-374-8461 · jblasi@ergclinical.com

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, FL 33912

    Site contact: Jacqueline Acosta · 239-939-7777 · recruitmentnprc@ergclinical.com

  • Conquest Research - Lake Nona

    Orlando, FL 32832

    Site contact: Daniela LaraRivillas · 407-916-0060 · Daniela.LaraRivillas@conquestresearch.com

  • Progressive Medical Research

    Port Orange, FL 32127

    Site contact: Kyrie Allen · 386-304-7070 · kyriem@progressivemedicalresearch.com

  • Alzheimer's Research and Treatment Center - Stuart

    Stuart, FL 34997

    Site contact: Adam Falchook, MD · 772-675-0000 · info@researchalz.com

  • Alzheimer's Research and Treatment Center - Wellington

    Wellington, FL 33414

    Site contact: Annet Falchook, MD · 561-209-2400 · info@researchalz.com

  • Columbus Memory Center

    Columbus, GA 31909

    Site contact: Mark Stafford · 706-653-8455 · info@researchalz.com

  • Center for Advanced Research & Education Flourish-Gainesville

    Gainsville, GA 30501

    Site contact: Tina Foreman · 770-534-5154 · tforeman@flourishresearch.com

  • Ascension via Christi Research

    Wichita, KS 67214

    Site contact: Angie Vincent · 316-268-6055 · angie.vincent@ascension.org

  • Tandem Clinical Research - Metairie

    Metairie, LA 70006

    Site contact: Tandem Clinical Research - Recruitment · 504-321-1700 · recruitment@tandemclinicalresearch.com

  • Headlands PharmaSite

    Pikesville, MD 21208

    Site contact: Aparna Ayyala · 410-699-9833 · aparna.ayyala@pharmasiteresearch.com

  • Adams Clinical Boston

    Boston, MA 02116

    Site contact: Megan Norris · 617-362-4386 · mnorris@adamsclinical.com

  • Headlands Research-EMA

    Plymouth, MA 02360

    Site contact: Jay Patel · 508-746-5060 · jay.patel@headlandsresearchema.com

  • Adams Clinical Watertown

    Watertown, MA 02472

    Site contact: Nova Chenda · 617-362-4386 · Nchenda@adamsclinical.com

  • Neurological Research Center - Hattiesburg Clinic

    Hattiesburg, MS 39401

    Site contact: Krista-Elizabeth Hanley · 601-579-5016 · bree.hanley@hattiesburgclinic.com

  • Clinical Research Professionals - Headlands

    Chesterfield, MO 63005

    Site contact: Recruitment · 636-220-1200 · recruitment@clinicalresearchprofessionals.net

  • CenExel Research - Toms River

    Toms River, NJ 08755

    Site contact: Anna Brocco · 732-341-9500 · amri.recruitment@cenexel.com

  • IMA Evaluations

    Albuquerque, NM 87109

    Site contact: Valerie Ramirez · 505-848-3773 · valerie.ramirez@imaresearch.com

  • Alzheimer's Disease Research Center

    Albany, NY 12208

    Site contact: Richard Holub, MD · 518-426-0575 · research@naaresearch.com

  • Adams Clinic Harlem

    New York, NY 10029

    Site contact: Outreach Recruitment Team · 646-917-6804 · jmoraleslu@adamsclinical.com

  • NDx Clinical Research

    Dayton, OH 45459

    Site contact: Study Team · 937-224-8200 · Contact@NdxResearch.com

  • Summitt Research

    Portland, OR 97210

    Site contact: Annika Truitt · 503-972-9822 · annika.truitt@summittnetwork.com

  • K2 Medical Research Nashville LLC

    Nashville, TN 37204

    Site contact: Victoria Marsh · 615-208-5252 · victoria.marsh@k2med.com

  • Kerwin Research Center, LLC - Oak Cliff

    Dallas, TX 75216

    Site contact: Megha Chadha · 972-433-9100 · enroll@kerwinmedical.com

  • Kerwin Research Center, LLC in Texas

    Dallas, TX 75231

    Site contact: Megha Chadha · 972-433-9100 · enroll@kerwinmedical.com

  • University of Virginia Adult Neurology

    Charlottesville, VA 22903

    Site contact: Colleen Webber · 434-243-5898 · cmn6x@virginia.edu

  • Northwest Clinical Research Center

    Bellevue, WA 98007

    Site contact: Study Coordinator · 425-453-0404 · study.coordinator@nwcrc.net

Study contacts (from the official record)

  • Joanna Bolger · 858-248-5124 · jbolger@lighthousepharma.com
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Study of LHP588 in Subjects With P. Gingivalis-Positive… (NCT06847321) | Bored Studies