Actively Recruiting
Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
Led by Lighthouse Pharmaceuticals, Inc. · Updated on 2026-05-05
300
Participants Needed
35
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial 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 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.
CONDITIONS
Official Title
Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Alzheimer's disease according to the National Institute on Aging-Alzheimer's Association criteria
- MMSE scores indicating mild to moderate Alzheimer's disease
- Positive saliva sample for P. gingivalis infection
- Plasma pTau217 level above cutoff
- Subject and caregiver have provided full 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, neurologic, or metabolic disease within 6 months prior to screening
- Unstable angina, symptomatic congestive heart failure (Grade 2 or higher), or myocardial infarction within 6 months
- Acute or poorly controlled blood pressure above 180 mmHg systolic or 100 mmHg diastolic at screening
- History or presence of major neurological or psychiatric illness such as schizophrenia, bipolar disorder, or Parkinson's disease
- Current treatment with anti-amyloid beta antibodies or other disease-modifying dementia treatments
- Any other condition judged by the investigator to interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 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
ATP Clinical Research, Inc.
Orange, California, United States, 92866
Actively Recruiting
5
JEM Research Institute
Atlantis, Florida, United States, 33462
Actively Recruiting
6
Brain Matters Research
Delray Beach, Florida, United States, 33445
Actively Recruiting
7
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States, 33912
Actively Recruiting
8
Conquest Research - Lake Nona
Orlando, Florida, United States, 32832
Actively Recruiting
9
Anchor Neuroscience
Pensacola, Florida, United States, 32502
Actively Recruiting
10
Alzheimer's Research and Treatment Center - Stuart
Stuart, Florida, United States, 34997
Actively Recruiting
11
Alzheimer's Research and Treatment Center - Wellington
Wellington, Florida, United States, 33414
Actively Recruiting
12
Columbus Memory Center
Columbus, Georgia, United States, 31909
Not Yet Recruiting
13
Center for Advanced Research & Education Flourish-Gainesville
Gainsville, Georgia, United States, 30501
Actively Recruiting
14
Cenexel Savannah GA
Savannah, Georgia, United States, 31405
Not Yet Recruiting
15
Ascension via Christi Research
Wichita, Kansas, United States, 67214
Not Yet Recruiting
16
Tandem Clinical Research - Metairie
Metairie, Louisiana, United States, 70006
Actively Recruiting
17
Headlands PharmaSite
Pikesville, Maryland, United States, 21208
Actively Recruiting
18
Adams Clinical Boston
Boston, Massachusetts, United States, 02116
Actively Recruiting
19
Headlands Research-EMA
Plymouth, Massachusetts, United States, 02360
Actively Recruiting
20
Adams Clinical Watertown
Watertown, Massachusetts, United States, 02472
Actively Recruiting
21
Neurological Research Center - Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
Actively Recruiting
22
Clinical Research Professionals - Headlands
Chesterfield, Missouri, United States, 63005
Actively Recruiting
23
CenExel Research - Toms River
Toms River, New Jersey, United States, 08755
Actively Recruiting
24
IMA Evaluations
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
25
Alzheimer's Disease Research Center
Albany, New York, United States, 12208
Actively Recruiting
26
Adams Clinic Harlem
New York, New York, United States, 10029
Not Yet Recruiting
27
Adams Clinical Bronx
The Bronx, New York, United States, 10461
Not Yet Recruiting
28
NDx Clinical Research
Dayton, Ohio, United States, 45459
Actively Recruiting
29
Summitt Research
Portland, Oregon, United States, 97210
Actively Recruiting
30
K2 Medical Research Nashville LLC
Nashville, Tennessee, United States, 37204
Actively Recruiting
31
Kerwin Research Center, LLC - Oak Cliff
Dallas, Texas, United States, 75216
Actively Recruiting
32
Kerwin Research Center, LLC in Texas
Dallas, Texas, United States, 75231
Actively Recruiting
33
University of Virginia Adult Neurology
Charlottesville, Virginia, United States, 22903
Actively Recruiting
34
Re-Cognition Health Fairfax
Fairfax, Virginia, United States, 22031
Actively Recruiting
35
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Actively Recruiting
Research Team
J
Joanna Bolger
CONTACT
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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