Testing LHP588 in Adults Aged 55 to 80 with P. Gingivalis-Positive Mild to Moderate Alzheimers Disease

What this Trial Is About

Researchers are evaluating LHP588 in people aged 55 to 80 with mild to moderate Alzheimers disease AD who have experienced mental decline in the past year and have an infection with P. gingivalis, a bacterium linked to dementia development. This randomized, double-blind, placebo-controlled Phase 2 study aims to assess the safety and effectiveness of LHP588 in slowing down or halting AD symptoms in participants with confirmed P. gingivalis infection and progressive cognitive decline. Participants will be randomly assigned to one of three groups a placebo group, a 25 mg LHP588 group, or a 50 mg LHP588 group. They will take the assigned oral capsules once daily in a fasted state for 48 weeks, with a 2-week dose increase period for the high dose group. The study includes a screening period of up to 12 weeks to confirm eligibility through tests including saliva sampling for P. gingivalis, blood tests for pTau217, cognitive questionnaires like MMSE, and brain MRI. After treatment, there is a 4-week safety follow-up to monitor overall health. Participants and their caregivers will attend at least 20 visits over the 64-week study period, plus at least one phone call for safety monitoring. Assessments include medical history, physical exams, saliva and blood samples, ECG, and cognitive and functional tests such as ADAS-Cog. Researchers will measure changes in cognition and daily functioning to evaluate the drugs impact. Caregiver involvement is required to assist with study participation and clinic visits throughout the trial.

Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease