Phase 2RecruitingAge-related condition
Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
A Randomized, Double-Blind, Placebo-Controlled Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
- Sponsor
- Lighthouse Pharmaceuticals, Inc. (Industry)
- Enrolment
- 300 planned
- Conditions
- Alzheimer Disease; Alzheimer Disease Due to P. Gingivalis
- Interventions
- LHP588; LHP588; Placebo Drug
- Ages
- adults, older adults
- Registry
- NCT06847321
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Change in ADAS-Cog11
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started