Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
Recruiting · NCT06847321 · Interventional (participants receive a specific treatment) · Lead sponsor: Lighthouse Pharmaceuticals, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
38 locations listed across 20 US states.
- Banner Alzheimer's Institute - Phoenix, Arizona, United States
- Barrow Neurological Institute - Phoenix, Arizona, United States
- Clinical Endpoints - Scottsdale, Arizona, United States
- Oakland Clinical Research - Oakland, California, United States
- ATP Clinical Research, Inc. - Orange, California, United States
- Riverside Clinical Research - Riverside, California, United States
- CenExel Sherman Oaks - Sherman Oaks, California, United States
- CenExel Denver, CO - Englewood, Colorado, United States
- JEM Research Institute - Atlantis, Florida, United States
- Brain Matters Research - Delray Beach, Florida, United States
- Neuropsychiatric Research Center of Southwest Florida - Fort Myers, Florida, United States
- Conquest Research - Lake Nona - Orlando, Florida, United States
- Anchor Neuroscience - Pensacola, Florida, United States
- Progressive Medical Research - Port Orange, Florida, United States
- Alzheimer's Research and Treatment Center - Stuart - Stuart, Florida, United States
- Alzheimer's Research and Treatment Center - Wellington - Wellington, Florida, United States
- Columbus Memory Center - Columbus, Georgia, United States
- Center for Advanced Research & Education Flourish-Gainesville - Gainsville, Georgia, United States
- Ascension via Christi Research - Wichita, Kansas, United States
- Tandem Clinical Research - Metairie - Metairie, Louisiana, United States
- Headlands PharmaSite - Pikesville, Maryland, United States
- Adams Clinical Boston - Boston, Massachusetts, United States
- Headlands Research-EMA - Plymouth, Massachusetts, United States
- Adams Clinical Watertown - Watertown, Massachusetts, United States
- Neurological Research Center - Hattiesburg Clinic - Hattiesburg, Mississippi, United States
- Clinical Research Professionals - Headlands - Chesterfield, Missouri, United States
- CenExel Research - Toms River - Toms River, New Jersey, United States
- IMA Evaluations - Albuquerque, New Mexico, United States
- Alzheimer's Disease Research Center - Albany, New York, United States
- Adams Clinic Harlem - New York, New York, United States
- NDx Clinical Research - Dayton, Ohio, United States
- Summitt Research - Portland, Oregon, United States
- K2 Medical Research Nashville LLC - Nashville, Tennessee, United States
- Kerwin Research Center, LLC - Oak Cliff - Dallas, Texas, United States
- Kerwin Research Center, LLC in Texas - Dallas, Texas, United States
- University of Virginia Adult Neurology - Charlottesville, Virginia, United States
- Re-Cognition Health Fairfax - Fairfax, Virginia, United States
- Northwest Clinical Research Center - Bellevue, Washington, United States