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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

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En resumen

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…

Fase 2300 participantes buscados38 centros1 país

Categorías

Neurología59%Enfermedades infecciosas28%Psiquiatría y salud mental13%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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.

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

Resumen

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).

Afecciones

  • Alzheimer Disease
  • Alzheimer Disease Due to P. Gingivalis

Elegibilidad

SexoTodos
Edades55 Years – 80 Years
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

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.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 2
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoQUADRUPLE (4)
Inscripción300 participantes buscados

Patrocinador y colaboradores

  • Lighthouse Pharmaceuticals, Inc. Patrocinador

Grupos e intervenciones

  • 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

Intervenciones

  • Fármaco LHP588

    25 mg, once daily

  • Fármaco LHP588

    50 mg, once daily

  • Fármaco Placebo Drug

    Placebo, once daily

Variables de resultado

  1. Variable de resultado principal

    Change in ADAS-Cog11

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

    Plazo 40 - 48 weeks

  2. Variable de resultado secundaria

    Change in ADCS-ADL

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

    Plazo 40 - 48 weeks

  3. Variable de resultado secundaria

    Change in CMAI

    CMAI is the Cohen-Mansfield Agitation Inventory

    Plazo 40 - 48 weeks

  4. Variable de resultado secundaria

    Change in CDR-SB

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

    Plazo 40 - 48 weeks

Fechas

Fecha de inicio17 de febrero de 2025 (real)
Finalización principal31 de enero de 2029 (estimada)
Finalización15 de marzo de 2029 (estimada)
Primera publicación26 de febrero de 2025 (real)
Última actualización15 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezjunio de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

37 centros están en reclutamiento

United States

CentroCiudadEstado o regiónEstado
Alzheimer's Disease Research CenterAlbanyNew YorkEn reclutamiento
IMA EvaluationsAlbuquerqueNew MexicoEn reclutamiento
JEM Research InstituteAtlantisFloridaEn reclutamiento
Northwest Clinical Research CenterBellevueWashingtonEn reclutamiento
Adams Clinical BostonBostonMassachusettsEn reclutamiento
University of Virginia Adult NeurologyCharlottesvilleVirginiaEn reclutamiento
Clinical Research Professionals - HeadlandsChesterfieldMissouriEn reclutamiento
Columbus Memory CenterColumbusGeorgiaEn reclutamiento
Kerwin Research Center, LLC - Oak CliffDallasTexasEn reclutamiento
Kerwin Research Center, LLC in TexasDallasTexasEn reclutamiento
NDx Clinical ResearchDaytonOhioEn reclutamiento
Brain Matters ResearchDelray BeachFloridaEn reclutamiento
CenExel Denver, COEnglewoodColoradoEn reclutamiento
Re-Cognition Health FairfaxFairfaxVirginiaEn reclutamiento
Neuropsychiatric Research Center of Southwest FloridaFort MyersFloridaEn reclutamiento
Center for Advanced Research & Education Flourish-GainesvilleGainsvilleGeorgiaEn reclutamiento
Neurological Research Center - Hattiesburg ClinicHattiesburgMississippiEn reclutamiento
Tandem Clinical Research - MetairieMetairieLouisianaEn reclutamiento
K2 Medical Research Nashville LLCNashvilleTennesseeEn reclutamiento
Adams Clinic HarlemNew YorkNew YorkEn reclutamiento
Oakland Clinical ResearchOaklandCaliforniaEn reclutamiento
ATP Clinical Research, Inc.OrangeCaliforniaEn reclutamiento
Conquest Research - Lake NonaOrlandoFloridaEn reclutamiento
Anchor NeurosciencePensacolaFloridaActivo, sin reclutar
Barrow Neurological InstitutePhoenixArizonaEn reclutamiento
Banner Alzheimer's InstitutePhoenixArizonaEn reclutamiento
Headlands PharmaSitePikesvilleMarylandEn reclutamiento
Headlands Research-EMAPlymouthMassachusettsEn reclutamiento
Progressive Medical ResearchPort OrangeFloridaEn reclutamiento
Summitt ResearchPortlandOregonEn reclutamiento
Riverside Clinical ResearchRiversideCaliforniaEn reclutamiento
Clinical EndpointsScottsdaleArizonaEn reclutamiento
CenExel Sherman OaksSherman OaksCaliforniaEn reclutamiento
Alzheimer's Research and Treatment Center - StuartStuartFloridaEn reclutamiento
CenExel Research - Toms RiverToms RiverNew JerseyEn reclutamiento
Adams Clinical WatertownWatertownMassachusettsEn reclutamiento
Alzheimer's Research and Treatment Center - WellingtonWellingtonFloridaEn reclutamiento
Ascension via Christi ResearchWichitaKansasEn reclutamiento

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 15 de septiembre de 2026

    Centro eliminado

    1 site removed (38 total)

    3938

  2. 8 de septiembre de 2026

    Centro eliminado

    1 site removed (39 total)

    4039

  3. 31 de julio de 2026

    Centro añadido

    1 site added (40 total)

    3940

Registro: ClinicalTrials.gov · NCT########

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