Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
Led by Lighthouse Pharmaceuticals, Inc. · Updated on 2026-06-03
300
Participants Needed
40
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating LHP588 in people aged 55 to 80 who have mild to moderate Alzheimer's disease (AD) with progressive mental decline over the last year and a specific infection caused by P. gingivalis bacteria. This infection has been linked to dementia development, and the study aims to assess if LHP588, which targets this bacterium, can potentially help slow AD progression. The study follows strict criteria including AD diagnosis by established guidelines and evidence of infection through saliva tests. Participants will be randomly assigned to one of three groups: a placebo group, a group receiving 25 mg of LHP588 daily, or a group receiving 50 mg daily. Treatment is given orally once a day in a fasted state for up to 48 weeks, including a 2-week dose increase period for the higher dose group. The study includes a screening phase lasting up to 12 weeks to confirm eligibility, followed by a 4-week safety follow-up after treatment ends. Throughout the study, participants and their caregivers will visit the study center about 20 times over 64 weeks for assessments including cognitive tests like the ADAS-Cog, MMSE, saliva and blood samples, neuroimaging, physical exams, and safety monitoring. Caregiver participation is essential. Researchers will measure changes in cognition and daily functioning to evaluate the study drug’s effects. After treatment, participants will have safety follow-ups including a phone call and a final visit at week 52.
CONDITIONS
Brief Title
Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Alzheimer's disease according to National Institute on Aging-Alzheimer's Association criteria
- MMSE scores indicating mild to moderate Alzheimer's disease
- Positive saliva test for P. gingivalis infection
- Plasma pTau217 level above cutoff
- Participant and caregiver have provided written informed consent
- Stable dose of acetylcholinesterase inhibitors and/or memantine for at least 90 days with no planned changes
- Modified Hachinski score of 4 or less at screening
You will not qualify if you...
- History of cancer requiring systemic therapy within the last 5 years
- Clinically significant unstable cardiovascular, pulmonary, renal, hepatic, gastrointestinal, neurological, or metabolic disease within 6 months prior to screening
- Unstable angina, symptomatic heart failure Grade 2 or higher, or recent myocardial infarction within 6 months
- Poorly controlled blood pressure above 180 mmHg systolic or 100 mmHg diastolic at screening
- History or current major neurological or psychiatric illness such as schizophrenia, bipolar disorder, or Parkinson's disease
- Currently treated with anti-amyloid beta antibodies or other disease-modifying dementia treatments
- Any other condition that may interfere with study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 12 weeks
Participants are screened for eligibility to participate in the trial.
At least 2 office visits
Duration - 48 weeks
Participants receive LHP588 or placebo orally once daily for 48 weeks to assess efficacy and safety.
Multiple visits during treatment including pharmacokinetic and biomarker blood sampling and cognitive assessments
Duration - 4 weeks
Participants are monitored for safety after treatment completion.
1 phone call and 1 follow-up visit
Trial Site Locations
Total: 40 locations
1
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Actively Recruiting
3
Clinical Endpoints
Scottsdale, Arizona, United States, 85258
Actively Recruiting
4
Oakland Clinical Research
Oakland, California, United States, 94609
Actively Recruiting
5
ATP Clinical Research, Inc.
Orange, California, United States, 92866
Actively Recruiting
6
Riverside Clinical Research
Riverside, California, United States, 92506
Not Yet Recruiting
7
CenExel Sherman Oaks
Sherman Oaks, California, United States, 91403
Actively Recruiting
8
CenExel Denver, CO
Englewood, Colorado, United States, 80113
Actively Recruiting
9
JEM Research Institute
Atlantis, Florida, United States, 33462
Actively Recruiting
10
Brain Matters Research
Delray Beach, Florida, United States, 33445
Actively Recruiting
11
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States, 33912
Actively Recruiting
12
Conquest Research - Lake Nona
Orlando, Florida, United States, 32832
Actively Recruiting
13
Anchor Neuroscience
Pensacola, Florida, United States, 32502
Actively Recruiting
14
Alzheimer's Research and Treatment Center - Stuart
Stuart, Florida, United States, 34997
Actively Recruiting
15
Alzheimer's Research and Treatment Center - Wellington
Wellington, Florida, United States, 33414
Actively Recruiting
16
Columbus Memory Center
Columbus, Georgia, United States, 31909
Actively Recruiting
17
Center for Advanced Research & Education Flourish-Gainesville
Gainsville, Georgia, United States, 30501
Actively Recruiting
18
Cenexel Savannah GA
Savannah, Georgia, United States, 31405
Not Yet Recruiting
19
Ascension via Christi Research
Wichita, Kansas, United States, 67214
Not Yet Recruiting
20
Tandem Clinical Research - Metairie
Metairie, Louisiana, United States, 70006
Actively Recruiting
21
Headlands PharmaSite
Pikesville, Maryland, United States, 21208
Actively Recruiting
22
Adams Clinical Boston
Boston, Massachusetts, United States, 02116
Actively Recruiting
23
Headlands Research-EMA
Plymouth, Massachusetts, United States, 02360
Actively Recruiting
24
Adams Clinical Watertown
Watertown, Massachusetts, United States, 02472
Actively Recruiting
25
Neurological Research Center - Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
Actively Recruiting
26
Clinical Research Professionals - Headlands
Chesterfield, Missouri, United States, 63005
Actively Recruiting
27
CenExel Research - Toms River
Toms River, New Jersey, United States, 08755
Actively Recruiting
28
IMA Evaluations
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
29
Alzheimer's Disease Research Center
Albany, New York, United States, 12208
Actively Recruiting
30
Adams Clinic Harlem
New York, New York, United States, 10029
Actively Recruiting
31
Adams Clinical Bronx
The Bronx, New York, United States, 10461
Actively Recruiting
32
NDx Clinical Research
Dayton, Ohio, United States, 45459
Actively Recruiting
33
Summitt Research
Portland, Oregon, United States, 97210
Actively Recruiting
34
K2 Medical Research Nashville LLC
Nashville, Tennessee, United States, 37204
Actively Recruiting
35
Kerwin Research Center, LLC - Oak Cliff
Dallas, Texas, United States, 75216
Actively Recruiting
36
Kerwin Research Center, LLC in Texas
Dallas, Texas, United States, 75231
Actively Recruiting
37
Re:Cognition Health - Houston
Houston, Texas, United States, 77030
Not Yet Recruiting
38
University of Virginia Adult Neurology
Charlottesville, Virginia, United States, 22903
Actively Recruiting
39
Re-Cognition Health Fairfax
Fairfax, Virginia, United States, 22031
Actively Recruiting
40
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Actively Recruiting
Research Team
J
Joanna Bolger
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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