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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-80
SponsorLighthouse Pharmaceuticals, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LHP588

    Drug

    25 mg, once daily

  • LHP588

    Drug

    50 mg, once daily

  • Placebo Drug

    Drug

    Placebo, once daily

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: LHP588 25 mgExperimental treatment 1 intervention
Group C: LHP588 50 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in ADAS-Cog11

ADAS-COG11 is the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11

Time frame
40 - 48 weeks

Secondary outcomes

1

Change in ADCS-ADL

ADCS-ADL is the Alzheimer's Disease Cooperative Study Group-Activities of Daily Living

Time frame
40 - 48 weeks
2

Change in CMAI

CMAI is the Cohen-Mansfield Agitation Inventory

Time frame
40 - 48 weeks
3

Change in CDR-SB

CDR-SB is the Clinical Dementia Rating-Sum of Boxes

Time frame
40 - 48 weeks

Other outcomes

Sponsors and contacts

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