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

Conditions

• Alzheimer Disease
• Alzheimer Disease Due to P. Gingivalis

Eligibility Criteria

Sex

ALL

Age

55 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• LHP588 — DRUG
  25 mg, once dialy
• LHP588 — DRUG
  50 mg, once daily
• Placebo Drug — DRUG
  Placebo, once daily

Study Details

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.

Key Dates

Start date

Feb 17, 2025

Status verified

Jun 2026

Primary completion

Jan 31, 2029

Completion

Mar 15, 2029

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Placebo capsule, once daily, for 48 weeks
• Experimental: LHP588 25 mg
  One 25 mg capsule, once daily, for 48 weeks
• Experimental: LHP588 50 mg
  Two 25 mg capsules, once daily, for 48 weeks

Primary Outcome Measure

Change in ADAS-Cog11 [ Time Frame: 40 - 48 weeks ]

Central Contacts

• Joanna Bolger
  858-248-5124
  [email protected]

Locations (40)

Find similar trials in Phoenix, AZ

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