NCT06847321ClinicalTrials.gov

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

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

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.

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Kurz gefasst

Phase 2300 Teilnehmende gesucht38 Studienzentren1 Land

Kategorien

Neurologie59%Infektionskrankheiten28%Psychiatrie und psychische Gesundheit13%

In 1 Register registriert

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Not stated: Registered after enrolment began (about 9 days after the recorded start)First posted 2025-02-26; recorded start 2025-02-17
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Not stated: No other studies from this sponsor are in this databaseCounted from the lead sponsor named in the record (Lighthouse Pharmaceuticals, Inc.)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 2 conditions.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 39 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration3/5
Registered within 30 days of the study start
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study: 300 participants (target), run at 38 sites.

How this score is built

Enrolment24/40
300 participants (target)
Site count19/25
39 sites
Country count0/15
Single country
Planned duration9/10
Planned over about 50 months
Sponsor scale0/10
Lighthouse Pharmaceuticals, Inc. has led 1 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Zusammenfassung

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.

This is a randomized, double-blind, placebo-controlled study that will assess the efficacy and safety of LHP588 in participants with evidence of P. gingivalis \[Pg\] infection and Alzheimer's Disease (AD) according to the National Institute on Aging-Alzheimer's Association (NIA-AA) research criteria. Enrolled participants must also have evidence of P. gingivalis infection as determined by polymerase chain reaction (PCR) of saliva oral rinse and clinical evidence of progressive cognitive decline in the last year. The participant should not have other conditions or brain imaging abnormalities that can explain the symptoms of dementia based on prior imaging and the screening magnetic resonance imaging (MRI). Due to the nature of AD, participants must identify a primary caregiver prior to enrollment in the study who will assist the participant with study participation and attend clinic visits. The study will consist of the following periods: 1) screening period of up to 12 weeks, 2) double-blind treatment period of 48 weeks (including a 2 week up-titration for the high dose arm), and 3) safety follow-up period of 4 weeks. The screening period will include at least two office visits during which eligibility will be verified. The first screening visit assessments will be limited to include the Mini-Mental State Examination (MMSE), saliva sample collection to assess Pg positivity, and pTau217 sample collection. The second screening visit will only be scheduled for participants with positive results of Pg infection and pTau217 test, and the rest of the screening procedures will be performed. Screening MRI will be performed as the last eligibility verification assessment. Participants who meet all eligibility criteria will be randomized in a 1:1:1 fashion to receive LHP588 25 mg, LHP588 50 mg, or placebo, orally, once daily (QD) in a fasted state (at least one hour before or two hours after a meal) for 48 weeks. Dosing should be done at approximately the same time each day. Blood samples for pharmacokinetics levels and biomarkers will be collected during selected visits. Evaluations will be conducted according to the schedule of assessments and will include: Medical history, physical examination, height, weight, saliva rinse for verification of Pg infection, blood for pharmacokinetic analysis, safely laboratory measures, electrocardiogram, and cognitive and functional scale assessments such as ADAS Cog, administered periodically. After completion of study treatment, participants will continue to be monitored for 4 weeks and will have a phone call to assess safety at Week 50 and will return for the Safety Follow-up Visit (Week 52).

Erkrankungen

Alzheimer Disease
Alzheimer Disease Due to P. Gingivalis

Eignung

Eignung
Geschlecht	Alle
Alter	55 Years – 80 Years
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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.

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 2
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	QUADRUPLE (4)
Teilnahme	300 Teilnehmende gesucht

Sponsor und Mitwirkende

Lighthouse Pharmaceuticals, Inc. Sponsor

Studienarme und Interventionen

PlaceboPLACEBO_COMPARATOR
Two (2) placebo capsules, once daily, for 48 weeks
LHP588 25 mgEXPERIMENTAL
One (1) 25 mg capsule and one (1) placebo capsule, once daily, for 48 weeks
LHP588 50 mgEXPERIMENTAL
Two (2) 25 mg capsules, once daily, for 48 weeks

Interventionen

Arzneimittel LHP588
25 mg, once daily
Arzneimittel LHP588
50 mg, once daily
Arzneimittel Placebo Drug
Placebo, once daily

Endpunkte

Primärer Endpunkt
Change in ADAS-Cog11
ADAS-COG11 is the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11
Zeitrahmen 40 - 48 weeks
Sekundärer Endpunkt
Change in ADCS-ADL
ADCS-ADL is the Alzheimer's Disease Cooperative Study Group-Activities of Daily Living
Zeitrahmen 40 - 48 weeks
Sekundärer Endpunkt
Change in CMAI
CMAI is the Cohen-Mansfield Agitation Inventory
Zeitrahmen 40 - 48 weeks
Sekundärer Endpunkt
Change in CDR-SB
CDR-SB is the Clinical Dementia Rating-Sum of Boxes
Zeitrahmen 40 - 48 weeks

Daten

Daten
Startdatum	17. Februar 2025 (tatsächlich)
Primärer Abschluss	31. Januar 2029 (geschätzt)
Abschluss	15. März 2029 (geschätzt)
Erstveröffentlichung	26. Februar 2025 (tatsächlich)
Zuletzt aktualisiert	15. September 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Juni 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

37 Studienzentren rekrutieren

United States

United States
Einrichtung	Stadt	Bundesland oder Region	Status
Alzheimer's Disease Research Center	Albany	New York	Rekrutiert
IMA Evaluations	Albuquerque	New Mexico	Rekrutiert
JEM Research Institute	Atlantis	Florida	Rekrutiert
Northwest Clinical Research Center	Bellevue	Washington	Rekrutiert
Adams Clinical Boston	Boston	Massachusetts	Rekrutiert
University of Virginia Adult Neurology	Charlottesville	Virginia	Rekrutiert
Clinical Research Professionals - Headlands	Chesterfield	Missouri	Rekrutiert
Columbus Memory Center	Columbus	Georgia	Rekrutiert
Kerwin Research Center, LLC - Oak Cliff	Dallas	Texas	Rekrutiert
Kerwin Research Center, LLC in Texas	Dallas	Texas	Rekrutiert
NDx Clinical Research	Dayton	Ohio	Rekrutiert
Brain Matters Research	Delray Beach	Florida	Rekrutiert
CenExel Denver, CO	Englewood	Colorado	Rekrutiert
Re-Cognition Health Fairfax	Fairfax	Virginia	Rekrutiert
Neuropsychiatric Research Center of Southwest Florida	Fort Myers	Florida	Rekrutiert
Center for Advanced Research & Education Flourish-Gainesville	Gainsville	Georgia	Rekrutiert
Neurological Research Center - Hattiesburg Clinic	Hattiesburg	Mississippi	Rekrutiert
Tandem Clinical Research - Metairie	Metairie	Louisiana	Rekrutiert
K2 Medical Research Nashville LLC	Nashville	Tennessee	Rekrutiert
Adams Clinic Harlem	New York	New York	Rekrutiert
Oakland Clinical Research	Oakland	California	Rekrutiert
ATP Clinical Research, Inc.	Orange	California	Rekrutiert
Conquest Research - Lake Nona	Orlando	Florida	Rekrutiert
Anchor Neuroscience	Pensacola	Florida	Aktiv, rekrutiert nicht
Barrow Neurological Institute	Phoenix	Arizona	Rekrutiert
Banner Alzheimer's Institute	Phoenix	Arizona	Rekrutiert
Headlands PharmaSite	Pikesville	Maryland	Rekrutiert
Headlands Research-EMA	Plymouth	Massachusetts	Rekrutiert
Progressive Medical Research	Port Orange	Florida	Rekrutiert
Summitt Research	Portland	Oregon	Rekrutiert
Riverside Clinical Research	Riverside	California	Rekrutiert
Clinical Endpoints	Scottsdale	Arizona	Rekrutiert
CenExel Sherman Oaks	Sherman Oaks	California	Rekrutiert
Alzheimer's Research and Treatment Center - Stuart	Stuart	Florida	Rekrutiert
CenExel Research - Toms River	Toms River	New Jersey	Rekrutiert
Adams Clinical Watertown	Watertown	Massachusetts	Rekrutiert
Alzheimer's Research and Treatment Center - Wellington	Wellington	Florida	Rekrutiert
Ascension via Christi Research	Wichita	Kansas	Rekrutiert

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

15. September 2026
Studienzentrum entfernt
1 site removed (38 total)
3938
8. September 2026
Studienzentrum entfernt
1 site removed (39 total)
4039
31. Juli 2026
Studienzentrum hinzugefügt
1 site added (40 total)
3940

https://xmedica.io/trials/ctgov/NCT06847321