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

Description

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 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 pTau 217. 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.

Conditions

Alzheimer Disease, Alzheimer Disease Due to P. Gingivalis

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Study Overview

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Study Details

Study overview

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 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 pTau 217. 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.

A Randomized, Double-Blind, Placebo-Controlled Study of LHP588 in Subjects with P. Gingivalis-Positive Alzheimer's Disease

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

Condition
Alzheimer Disease
Intervention / Treatment

-

Contacts and Locations

Bellevue

Northwest Clinical Research Center, Bellevue, Washington, United States, 98007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * AD according to the National Institute on Aging-Alzheimer's Association criteria.
  • * MMSE score between 12 and 24.
  • * 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.
  • * 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.

Ages Eligible for Study

55 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Lighthouse Pharmaceuticals, Inc.,

Study Record Dates

2028-12