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

Summary

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.

Interventions

• LHP588 · DRUG

  25 mg, once daily

• LHP588 · DRUG

  50 mg, once daily

• Placebo Drug · DRUG

  Placebo, once daily

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion 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.

Exclusion Criteria:

* 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.

Sites (40)

• Banner Alzheimer's Institute, Phoenix, Arizona · RECRUITING
• Barrow Neurological Institute, Phoenix, Arizona · RECRUITING
• Clinical Endpoints, Scottsdale, Arizona · RECRUITING
• Oakland Clinical Research, Oakland, California · RECRUITING
• ATP Clinical Research, Inc., Orange, California · RECRUITING
• Riverside Clinical Research, Riverside, California · RECRUITING
• CenExel Sherman Oaks, Sherman Oaks, California · RECRUITING
• CenExel Denver, CO, Englewood, Colorado · RECRUITING
• JEM Research Institute, Atlantis, Florida · RECRUITING
• Brain Matters Research, Delray Beach, Florida · RECRUITING
• Neuropsychiatric Research Center of Southwest Florida, Fort Myers, Florida · RECRUITING
• Conquest Research - Lake Nona, Orlando, Florida · RECRUITING
• Anchor Neuroscience, Pensacola, Florida · RECRUITING
• Progressive Medical Research, Port Orange, Florida · RECRUITING
• Alzheimer's Research and Treatment Center - Stuart, Stuart, Florida · RECRUITING
• Alzheimer's Research and Treatment Center - Wellington, Wellington, Florida · RECRUITING
• Columbus Memory Center, Columbus, Georgia · RECRUITING
• Center for Advanced Research & Education Flourish-Gainesville, Gainsville, Georgia · RECRUITING
• Cenexel Savannah GA, Savannah, Georgia · ACTIVE_NOT_RECRUITING
• Ascension via Christi Research, Wichita, Kansas · RECRUITING
• Tandem Clinical Research - Metairie, Metairie, Louisiana · RECRUITING
• Headlands PharmaSite, Pikesville, Maryland · RECRUITING
• Adams Clinical Boston, Boston, Massachusetts · RECRUITING
• Headlands Research-EMA, Plymouth, Massachusetts · RECRUITING
• Adams Clinical Watertown, Watertown, Massachusetts · RECRUITING
• Neurological Research Center - Hattiesburg Clinic, Hattiesburg, Mississippi · RECRUITING
• Clinical Research Professionals - Headlands, Chesterfield, Missouri · RECRUITING
• CenExel Research - Toms River, Toms River, New Jersey · RECRUITING
• IMA Evaluations, Albuquerque, New Mexico · RECRUITING
• Alzheimer's Disease Research Center, Albany, New York · RECRUITING
• Adams Clinic Harlem, New York, New York · RECRUITING
• Adams Clinical Bronx, The Bronx, New York · ACTIVE_NOT_RECRUITING
• NDx Clinical Research, Dayton, Ohio · RECRUITING
• Summitt Research, Portland, Oregon · RECRUITING
• K2 Medical Research Nashville LLC, Nashville, Tennessee · RECRUITING
• Kerwin Research Center, LLC - Oak Cliff, Dallas, Texas · RECRUITING
• Kerwin Research Center, LLC in Texas, Dallas, Texas · RECRUITING
• University of Virginia Adult Neurology, Charlottesville, Virginia · RECRUITING
• Re-Cognition Health Fairfax, Fairfax, Virginia · RECRUITING
• Northwest Clinical Research Center, Bellevue, Washington · RECRUITING