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NCT06847321 · ClinicalTrials.gov registry record · Phase 2
Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
A Phase 2 study of Alzheimer Disease and Alzheimer Disease Due to P. Gingivalis, sponsored by Lighthouse Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT06847321: Recruiting Phase 2 study of Alzheimer Disease and Alzheimer Disease Due to P. Gingivalis, sponsored by Lighthouse Pharmaceuticals.
NCT06847321 is a Phase 2 study of Alzheimer Disease and Alzheimer Disease Due to P. Gingivalis that is actively recruiting participants, run by Lighthouse Pharmaceuticals. The registered enrollment target is 300 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06847321, a Phase 2 study of Alzheimer Disease and Alzheimer Disease Due to P. Gingivalis, is actively recruiting participants, sponsored by Lighthouse Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
ADAS-COG11 is the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11
Conditions Studied
Interventions
- DRUG LHP588
- DRUG Placebo Drug
Study Locations (1)
Washington
- Northwest Clinical Research Center - Bellevue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2025-02-17 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
What NCT06847321 shows while recruiting
NCT06847321 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which LHP588 is the first listed.
NCT06847321 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT06847321 about?
NCT06847321 is a clinical study titled "Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease". 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. ging...
What is the current status of trial NCT06847321?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2025-02-17. Estimated completion is 2028-12.
What conditions does trial NCT06847321 study?
This clinical trial studies the following conditions: Alzheimer Disease, Alzheimer Disease Due to P. Gingivalis.
What interventions are being tested in trial NCT06847321?
The interventions under investigation include: LHP588 (DRUG), Placebo Drug (DRUG).
Who is sponsoring clinical trial NCT06847321?
This trial is sponsored by Lighthouse Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06847321 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06847321's enrollment target sits among peer trials
300 79th of 306 higher than 225 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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