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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Time periods mentioned: 64 weeks, 12 weeks, 48 weeks, 4 weeks
  • Procedures mentioned: Blood draws, Questionnaires, Pills, MRI scans, Heart tracing (ECG), Physical exams, Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Tests for AD include standard questionnaires such as MMSE and a blood test for pTau217."
  • "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."
  • "The study will consist of the following periods: 1) screening period of up to 12 weeks, 2) double-blind treatment period of 48 weeks (including a 2 week up-titration for the high dose arm), and 3) safety follow-up period of 4 weeks."
  • "The screening period will include at least two office visits during which eligibility will be verified."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether LHP588, a daily capsule that targets P. gingivalis bacteria, may slow Alzheimer's disease and its symptoms. It is for people with mild to moderate Alzheimer's disease whose thinking has worsened over the past year and who have this infection. The study may last up to 64 weeks and requires a caregiver to join at least 20 study visits.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Alzheimer's disease based on standard medical guidelines.
  • Have a score on the MMSE thinking and memory test that shows mild to moderate Alzheimer's disease.
  • Have a saliva rinse test that shows P. gingivalis bacteria.
  • Have a blood level of pTau217, a marker used to test for Alzheimer's disease, above the study's cutoff.
  • You and your caregiver must give written consent to join.
  • If taking certain Alzheimer's medicines, such as memantine or acetylcholinesterase inhibitors, the dose must be unchanged for 90 days, with no changes planned during the study.
  • Have a Modified Hachinski score of 4 or less at screening. This score checks for signs that blood vessel problems may affect thinking.

Who can't join

  • Have had cancer that needed treatment affecting the whole body within the past 5 years.
  • Have had a serious, unstable disease within 6 months before screening that affects the heart, lungs, kidneys, liver, digestion, brain, nerves, or how the body uses energy.
  • Have unstable chest pain from heart disease, heart failure with symptoms or poor control, or a heart attack within the past 6 months.
  • Have sudden or poorly controlled high blood pressure at screening: a top number above 180 or a bottom number above 100.
  • Have a past or current major brain, nerve, or mental health illness, such as schizophrenia, bipolar disorder, or Parkinson's disease.
  • Are receiving anti-amyloid beta antibodies or other treatments meant to change the course of dementia.
  • Have another condition or issue that the study doctor thinks may prevent you from taking part.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (39)

AZ

CA

CO

FL

GA

KS

LA

MA

MD

MO

MS

NJ

NM

NY

OH

OR

TN

TX

VA

WA