Alzheimer Disease study: LHP588
Official title Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
ClinicalTrials.gov ID: NCT06847321
What this study is testing
What is LHP588?
This is an investigational once-daily capsule being studied as a potential treatment for mild to moderate Alzheimer's disease. It is designed to target the P. gingivalis bacterium, which has been linked to dementia.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether LHP588 can slow the decline in Alzheimer’s disease caused by a gum bacteria. It also looks at how safe the capsule is.
- Who it's for
- You may be able to join if you have mild or moderate Alzheimer’s, have gotten worse in the last year, and have the gum bacteria P. gingivalis.
- What's involved
- You will take one capsule each day and bring a caregiver to the clinic. You will have saliva and blood tests, answer questionnaires, and talk to the study team by phone. The doctor and you will not know if you get the real capsule or a pretend one.
- Time commitment
- The study lasts up to 64 weeks, with about 20 clinic visits and one phone call. It includes a 12‑week screening, 48‑week treatment, and a 4‑week safety check after the last dose.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 48 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 80
You may be able to join if
- 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.
You likely can't join if
- 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...
- Unstable angina, uncompensated and/or symptomatic congestive heart failure (Grade 2 or higher on the New York Heart Association scale) or myocardial...
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Murrieta, California, United States
- Oakland, California, United States
- Orange, California, United States
- Riverside, California, United States
- Sherman Oaks, California, United States
- Englewood, Colorado, United States
- Atlantis, Florida, United States
- Delray Beach, Florida, United States
- Fort Myers, Florida, United States
- Orlando, Florida, United States
- Port Orange, Florida, United States
- Stuart, Florida, United States
- Wellington, Florida, United States
- Columbus, Georgia, United States
- Gainsville, Georgia, United States
- Wichita, Kansas, United States
- Metairie, Louisiana, United States
- Pikesville, Maryland, United States
+ 15 more site(s).
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 48 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Murrieta, California, United States; Oakland, California, United States; Orange, California, United States; Riverside, California, United States and 29 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.