Study of LHP588 for Alzheimer's Disease with P. Gingivalis Infection
This study is testing a drug called LHP588 in people aged 55 to 80 who have mild to moderate Alzheimer's disease (AD) and also have a specific infection called P. gingivalis. P. gingivalis is a type of bacteria that has been linked to dementia. LHP588 is designed to target this bacterium, with the goal of potentially slowing down the progression of AD symptoms. To join, you would need to have AD based on specific criteria, show progressive mental decline, and have P. gingivalis detected in a saliva test. You would also need a blood test showing a certain level of pTau217, a marker for AD. The main way we'll know if LHP588 is working is by measuring changes in your ADAS-Cog11 score, a test of cognitive function, after about 40 to 48 weeks. This study is currently unclear on its recruitment status.
- Study design
- This is a randomized, double-blind, placebo-controlled study with a planned enrollment of 300 participants. This means participants will be randomly assigned to receive LHP588 (either 25 mg or 50 mg once daily) or a placebo, and neither you nor your doctor will know which you are receiving.
- What's involved
- Your total participation in the study could last up to 64 weeks, including a screening period of up to 12 weeks, a treatment period of 48 weeks, and a safety follow-up period of 4 weeks. You will need a primary caregiver to assist with your participation and attend clinic visits.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety for 4 weeks after the treatment period ends.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
At a glance
Conditions
Where it's being run
40 sites across 20 statesStudy leadership
- Stephen Dominy, MD · STUDY_DIRECTOR · Lighthouse Pharmaceuticals, Inc.
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in ADAS-Cog1140 - 48 weeks
ADAS-COG11 is the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11