About this trial
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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
LHP588
Drug25 mg, once daily
LHP588
Drug50 mg, once daily
Placebo Drug
DrugPlacebo, once daily
Treatment groups
Trial outcomes
Primary outcomes
Change in ADAS-Cog11
ADAS-COG11 is the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11
Secondary outcomes
Change in ADCS-ADL
ADCS-ADL is the Alzheimer's Disease Cooperative Study Group-Activities of Daily Living
Change in CMAI
CMAI is the Cohen-Mansfield Agitation Inventory
Change in CDR-SB
CDR-SB is the Clinical Dementia Rating-Sum of Boxes
Sponsors and contacts
Click on the lead sponsor to view all of their trials.