Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
Recruiting
Phase 2Interventional Study
Alzheimer DiseaseAlzheimer Disease Due to P. Gingivalis
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
55 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Lighthouse Pharmaceuticals, Inc. · Industry
Who this trial is looking for
This trial is looking for people with mild to moderate Alzheimer's who also have a specific infection. Participants will take a daily capsule and attend study visits over 64 weeks.
Are You a Good Fit for This Trial?
Must be takingAcetylcholinesterase inhibitorsMemantine
Rules you outUnstable anginaCongestive heart failureMyocardial infarction
You may be able to join if
I have been diagnosed with Alzheimer's disease
I have a positive saliva test for P. gingivalis
I have mild to moderate Alzheimer's based on standard tests
My blood test for pTau217 is above the cutoff
I can give written consent
My caregiver can also provide consent
I have stable background treatment for Alzheimer's if applicable
My Modified Hachinski score is 4 or less
You may not be able to join if
I have had cancer requiring therapy in the last 5 years
I have had significant health issues in the last 6 months
I have unstable heart conditions or a heart attack in the last 6 months
My blood pressure is too high at the screening visit
I have a major neurological or psychiatric illness
I am currently being treated with anti-amyloid beta antibodies or similar treatments
The study doctor believes I can't participate for another reason
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 sympto…
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.
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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 c…
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.
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