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AzTrials

Alzheimer's Disease PsychosisPhase 2/3NCT06159673

ACP-204 in Adults With Alzheimer's Disease Psychosis

A Phase 2/3 study testing ACP-204 in people with Alzheimer's Disease Psychosis, run by ACADIA Pharmaceuticals Inc. at 155 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first. Read more about this study

Who is it for?
Ages 55 to 95 years
Conditions the study is for
Alzheimer's Disease Psychosis
What is being tested?
ACP-204
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,074 participants
Where
155 sitesin 12 countries
Study dates
14 Nov 2023to Feb 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Is male or female and ≥55 and ≤95 years of age living in the community or in an institutionalized setting
  • Meets clinical criteria for possible or probable AD based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria
  • Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association (IPA)
  • Has either blood-based biomarker or documented evidence (e.g. positron emission tomography, cerebrospinal fluid biomarker) indicating amyloid plaque deposition and neuropathologic change consistent with AD
  • Has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of AD
  • Meets revised criteria for psychosis in major or mild neurocognitive disorder as per International Psychogeriatrics Association
Show all 12Show fewer
  • MMSE score ≥6 and ≤24
  • Psychotic symptoms for at least 2 months
  • Lives in a stable place of residence and there are no plans to change living arrangements
  • Has a designated study partner/caregiver
  • Able to complete all study visits with a study partner/caregiver
  • Must be on a stable dose of cholinesterase inhibitor or memantine, if applicable

Who cannot join

  • Requires treatment with a medication prohibited by the protocol
  • Is in hospice and receiving end-of-life palliative care, or has become bedridden
  • Requires skilled nursing care
  • Psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition other than dementia
  • Known history of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, or unexplained syncope
  • Atrial fibrillation
Show all 10Show fewer
  • Symptomatic orthostatic hypotension
  • Protocol-defined exclusionary clinical laboratory findings
  • Treatment with anti-tau therapy or donanemab within 2 months prior to Screening
  • Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Trial locations and contacts

155 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Christine Murphy contact

858-465-7480

cmurphy@acadia-pharm.com

Kristen White contact

813-838-6468

kristen.white@acadia-pharm.com

155 sites in 12 countries

United States53 sites, 36 recruiting

  • Abington Neurological Associates

    Abington, Pennsylvania, 19001

    Recruiting

  • Dent Neurologic Institute

    Amherst, New York, 14226

    Withdrawn

  • Advanced Research Center, Inc.

    Anaheim, California, 92805

    Withdrawn

  • Agile Clinical Research Trials LLC

    Atlanta, Georgia, 30328

    Recruiting

  • Humanity Clinical Research Corp

    Aventura, Florida, 33180

    Recruiting

  • Insight Clinical Trials LLC

    Beachwood, Ohio, 44122

    Withdrawn

  • Valley Medical Research

    Centerville, Ohio, 45459

    Withdrawn

  • Chandler Clinical Trials

    Chandler, Arizona, 85224

    Withdrawn

  • ATP Clinical Research

    Costa Mesa, California, 92626

    Recruiting

  • Horizon Clinical Research Group

    Cypress, Texas, 77429

    Recruiting

  • NDx Clinical Research Inc.

    Dayton, Ohio, 45459

    Recruiting

  • Arrow Clinical Trials

    Daytona Beach, Florida, 32117

    Recruiting

  • First Excellent Research Group

    Doral, Florida, 33178

    Recruiting

  • Revive Research Institute, Inc.

    Elgin, Illinois, 60123

    Withdrawn

  • Neuro-Pain Medical Center

    Fresno, California, 93710

    Recruiting

  • CBH Health LLC, dba CenExcel Gaithersburg

    Gaithersburg, Maryland, 20877

    Recruiting

  • National Institute of Clinical Research

    Garden Grove, California, 92844

    Terminated

  • New Life Medical Research Center Inc.

    Hialeah, Florida, 33012

    Recruiting

  • Reliable Clinical Research LLC.

    Hialeah, Florida, 33012

    Recruiting

  • Prolato Clinical Research Center-Patton

    Houston, Texas, 77054

    Recruiting

  • University of Texas Health Science Center

    Houston, Texas, 77054

    Terminated

  • Clinical Trial Network LLC

    Houston, Texas, 77074

    Recruiting

  • Kaleidoscope Clinical Research

    Houston, Texas, 77089

    Recruiting

  • Steven South Goldstein MD and Associates

    Houston, Texas, 77089

    Recruiting

  • Alivation Research, LLC

    Lincoln, Nebraska, 68526

    Withdrawn

  • Advanced Memory Research Institute of New Jersey

    Marlton, New Jersey, 08053

    Recruiting

  • Homestead Associates in Research Inc.

    Miami, Florida, 33032

    Recruiting

  • Premier Clinical Research Institute, Inc.

    Miami, Florida, 33122

    Recruiting

  • Central Miami Medical Institute

    Miami, Florida, 33125

    Withdrawn

  • Advanced Clinical Research Network, Corp

    Miami, Florida, 33135

    Recruiting

  • Verus Clinical Research

    Miami, Florida, 33135

    Recruiting

  • Future Care Solution, LLC

    Miami, Florida, 33165

    Recruiting

  • MediClear Medical & Research Center, Inc.

    Miami, Florida, 33165

    Recruiting

  • ABBA Medical Group LLC

    Miami, Florida, 33176

    Recruiting

  • Visionary Investigators Network

    Miami, Florida, 33176

    Withdrawn

  • Quantum Clinical Trials

    Miami Beach, Florida, 33140

    Recruiting

  • New Med Research

    Miami Gardens, Florida, 33056

    Recruiting

  • Floridian Neuroscience Institutue

    Miami Lakes, Florida, 33016

    Recruiting

  • Combined Research Orlando Phase I IV

    Orlando, Florida, 32807

    Recruiting

  • Havana Research Institute LLC

    Pasadena, California, 91105-3264

    Recruiting

  • Quantum Clinical Research, Inc.

    Pasadena, California, 91106

    Recruiting

  • World Research Link

    Pasadena, Texas, 77504

    Recruiting

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

    Withdrawn

  • Khan Revive Research Institute

    Rochester Hills, Michigan, 48307

    Withdrawn

  • Clinical Endpoint LLC

    Scottsdale, Arizona, 85258

    Recruiting

  • Grace Research, LLC

    Shreveport, Louisiana, 71105

    Recruiting

  • Tekton Research, LLC

    St Louis, Missouri, 63128

    Recruiting

  • R & H Clinical Research Inc.

    Stafford, Texas, 77477

    Withdrawn

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

    Recruiting

  • Psych Me Medical Research Inc

    Tampa, Florida, 33614

    Withdrawn

  • Regional Neurological Associates

    The Bronx, New York, 10466

    Withdrawn

  • Tranquil Clinical Research

    Webster, Texas, 77598

    Withdrawn

  • Neuroscience Research Institute

    West Palm Beach, Florida, 33407

    Recruiting

Other trials in United States

Brazil15 sites, 13 recruiting

  • L2IP - Instituto de Pesquisas Clínicas Ltda

    Brasília, 70200-730

    Recruiting

  • Hospital Universitario de Brasilia

    Brasília, 70840-901

    Recruiting

  • CECPAR Centro de Estudos Clinicos do Parana

    Curitiba, 80030-310

    Recruiting

  • TrialTech Tecnologia com Pesquisas em Medicamentos

    Curitiba, 80240-280

    Recruiting

  • Inst. de Neurologia de Curitiba Hospital Ecoville

    Curitiba, 81210-310

    Recruiting

  • Clinica Neurologica e Neurocirurgica de Joinville

    Joinville, Santa Catarina, 89202-190

    Recruiting

  • Instituto Mederi de Pesquisa e Saude

    Passo Fundo, 99010-120

    Recruiting

  • Hospital Moinhos de Vento

    Porto Alegre, 90035-001

    Recruiting

  • Nucleo de Pesquisa Clínica do Rio Grande do Sul

    Porto Alegre, 90430-001

    Withdrawn

  • Ruschel Medicina e Pesquisa Clínica

    Rio de Janeiro, 22270-060

    Recruiting

  • Facili-Centro Integrado de Psiquiatria

    São Bernardo do Campo, 09726-150

    Recruiting

  • BR Trials-Ensaios Clinicos e Consultoria

    São Paulo, 01236-030

    Recruiting

  • Hospital Sao Paulo

    São Paulo, 04024-002

    Recruiting

  • Santa Paula Hospital Clinical Research Center

    São Paulo, 04550-000

    Recruiting

  • Hospital das Clínicas da Faculdade de Medicina USP

    São Paulo, 05403-000

    Withdrawn

Other trials in Brazil

Serbia14 sites, 1 recruiting

  • Clinical Hosp Center Dr Dragisa Misovic Dedinje

    Belgrade, 11000

    Active, not recruiting

  • Clinical. Hospital Center Zvezdara

    Belgrade, 11000

    Active, not recruiting

  • Institute of Mental Health

    Belgrade, 11000

    Active, not recruiting

  • Special Hospital for Cerebrovascular Disease Sveti Sava

    Belgrade, 11000

    Active, not recruiting

  • University Clinic Centre of Serbia

    Belgrade, 11000

    Recruiting

  • Special Hospital for Psychiatric Diseases

    Gornja Toponica, 18202

    Active, not recruiting

  • Spl. Hosp. for Psychiatric Diseases Kovin

    Kovin, 26220

    Terminated

  • Janjic University Clinical Center Kragujevac

    Kragujevac, 34000

    Active, not recruiting

  • Jovanovic University Clinical Centre of Kragujevac

    Kragujevac, 34000

    Active, not recruiting

  • University Clinical Center Kragujevac

    Kragujevac, 34000

    Active, not recruiting

  • University Clinical Center Nis

    Niš, 18000

    Active, not recruiting

  • Spl. Hosp. for Psychiatric Diseases Sveti Vracevi

    Novi Kneževac, 23330

    Withdrawn

  • Gen. Hosp. Dr Radivoj Simonovic

    Sombor, 25000

    Withdrawn

  • General Hospital Valjevo

    Valjevo, 14000

    Withdrawn

Other trials in Serbia

Bulgaria13 sites

  • ET Dr. Ivo Natsov - AIPSMC in Psychiatry

    Cherven Bryag, 5980

    Active, not recruiting

  • Medical Center Lifemed

    Kardzhali, 6600

    Withdrawn

  • DCC "Higia"

    Pazardzhik, 4400

    Active, not recruiting

  • Medical center Medconsult Pleven OOD

    Pleven, 5800

    Active, not recruiting

  • UMHAT Sv. Georgi EAD

    Plovdiv, 4000

    Withdrawn

  • Medical center Spectar-Plovdic EOOD

    Plovdiv, 4004

    Withdrawn

  • Mental Health Centre - Prof. N Shipkovenski EOOD

    Sofia, 1377

    Active, not recruiting

  • DCC St. Vrach and St. St. Kuzma and Damian OOD

    Sofia, 1408

    Active, not recruiting

  • UMHAT "Alexandrovska" EAD

    Sofia, 1431

    Active, not recruiting

  • UMHAT Alexandrovska EAD

    Sofia, 1431

    Active, not recruiting

  • Medical Center Hera EOOD

    Sofia, 1510

    Withdrawn

  • Medical Center Intermedica

    Sofia, 1680

    Withdrawn

  • UMHAT Prof. Dr. St. Kirkovich AD

    Stara Zagora, 6003

    Withdrawn

Other trials in Bulgaria

France12 sites

  • Hopital Neurologique Bron

    Bron, 69677

    Withdrawn

  • Centre pour Personnes Âgées

    Colmar, 68000

    Withdrawn

  • Centre Memoire Ressources Recherche CMRR

    Dijon, 21000

    Active, not recruiting

  • CHU de Limoges-Hopital Dupuytren

    Limoges, 87042

    Active, not recruiting

  • Hospices Civils de Lyon HCL

    Lyon, 69002

    Withdrawn

  • Hôpital Lariboisière

    Paris, 75010

    Active, not recruiting

  • Hopital BROCA

    Paris, 75013

    Active, not recruiting

  • CHU Rouen-Hospital Charles Nicolle

    Rouen, 76031

    Active, not recruiting

  • Hopital Purpan

    Toulouse, 31059

    Withdrawn

  • Hôpital La Grave

    Toulouse, 31059

    Active, not recruiting

  • CHRU de Tours- Hopital Bretonneau

    Tours, 37044

    Active, not recruiting

  • Hôpital de Brabois Adultes

    Vandœuvre-lès-Nancy, 545000

    Active, not recruiting

Other trials in France

Mexico11 sites, 11 recruiting

  • Hospital Universitario Dr. Gonzalo Valdes Valdes

    Coahuila, 25000

    Recruiting

  • Clinical Research Institute S.C

    Estado de México, 54055

    Recruiting

  • B&B Investigaciones Medicas SC

    Mazatlán, 82140

    Recruiting

  • Health Pharma Professional Research S.A. de C.V.

    Mexico City, 03100

    Recruiting

  • Mexico Centre for Clinical Research S.A de C.V

    Mexico City, 03100

    Recruiting

  • Iecsi S.C.

    Monterrey, N.L, 64310

    Recruiting

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460

    Recruiting

  • Centro Estudios Clínicos y Esp. Médicas SC CECEM

    Nuevo León, 64620

    Recruiting

  • BIND Investigaciones S.C.

    San Luis Potosí City, 78213

    Recruiting

  • Neurociencias Estudios Clinicos

    Sinaloa, 80020

    Recruiting

  • Centro para el Des de la Med y de Asist Med Esp SC

    Sinaloa, 80230

    Recruiting

Other trials in Mexico

Italy10 sites

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123

    Active, not recruiting

  • Neurologia-Fondazione Instituto G. Giglio

    Cefalù, 90015

    Active, not recruiting

  • IRCCS Neuromed Istituto Neurologico Mediterraneo

    Isernia, 86077

    Withdrawn

  • Ospedale San Raffaele

    Milan, 20132

    Withdrawn

  • Fondazione Policlinico Uni Campus Bio-Medico di Roma

    Roma, 00128

    Active, not recruiting

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168

    Active, not recruiting

  • AOU Policlinico Umberto I

    Roma, 00185

    Withdrawn

  • Azienda Ospedaliera Universitaria OO. RR. S.

    Salerno, 84131

    Active, not recruiting

  • Dipartimento di Neuroscienze Rita Levi Montalcini

    Torino, 10126

    Withdrawn

  • Azienda Ospedaliera Card. G. Panico

    Tricase, 73039

    Active, not recruiting

Other trials in Italy

Czechia8 sites

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91

    Active, not recruiting

  • NEUROHK s.r.o

    Choceň, 56501

    Active, not recruiting

  • BRAIN-SOUL THERAPY s.r.o.

    Kladno, Czech Republic, 27201

    Active, not recruiting

  • Ad71 S.R.O.

    Prague, Czech Republic, 109 00

    Active, not recruiting

  • CLINTRIAL s.r.o.

    Prague, 100 00

    Active, not recruiting

  • FORBELI s.r.o.

    Prague, 160 00

    Withdrawn

  • INEP medical s.r.o

    Prague, 186 00

    Withdrawn

  • Vestra Clinics s.r.o.

    Rychnov nad Kněžnou, 516 01

    Active, not recruiting

Other trials in Czechia

South Korea8 sites, 5 recruiting

  • Gachon University Gil Medical Center

    Incheon, 21565

    Recruiting

  • Inha University Hospital

    Incheon, 22332

    Recruiting

  • Korea University Anam Hospital

    Seoul, 02841

    Recruiting

  • Eunpyeong St. Mary's Hospital

    Seoul, 03312

    Terminated

  • Hanyang University Seoul Hospital

    Seoul, 04763

    Terminated

  • Konkuk University Medical Center

    Seoul, 05030

    Withdrawn

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • SMG-SNU Boramae Medical Center

    Seoul, 07061

    Recruiting

Other trials in South Korea

Taiwan5 sites, 3 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

    Recruiting

  • E-DA Hospital

    Kaohsiung City

    Recruiting

  • Taipei Medical University-Shuang Ho Hospital

    New Taipei City, 23561

    Withdrawn

  • National Cheng Kung University Hospital

    Tainan, 704

    Withdrawn

  • National Taiwan University Hospital

    Taipei, 10002

    Recruiting

Other trials in Taiwan

Chile4 sites, 4 recruiting

  • Psicomed Estudios Medicos

    Antofagasta, 1270244

    Recruiting

  • Biomedica Research Group

    Santiago, 7500710

    Recruiting

  • Especialidades Medicas L y S

    Santiago, 7560356

    Recruiting

  • CIC de la Universidad Catolica CICUC

    Santiago, 8330024

    Recruiting

Other trials in Chile

Spain2 sites

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Active, not recruiting

  • Hospital Provincial de Zamora

    Zamora, 49021

    Active, not recruiting

Other trials in Spain

About this study

Official title: A Master Protocol for Three Independent, Seamlessly Enrolling, Double-blind, Placebo-controlled Efficacy and Safety Studies of ACP-204 in Adults With Alzheimer's Disease Psychosis

This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP

  • Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first.
  • Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1.
Read more

All 3 substudies will be analyzed independently of each other.

Each substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).

Being tested
ACP-204, Placebo
Keywords
Alzheimer's disease psychosis, Hallucinations, Delusions
Medical subject headings
Hallucinations, Delusions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACP-204Drug

    ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.

  • PlaceboDrug

    ACP-204 matching placebo

Study groups in NCT06159673
Study groupRoleWhat they receive
ACP-204 30 mgExperimentalAdministration once daily at approximately the same time of day, with or without food
Receives: Drug: ACP-204
ACP-204 60 mgExperimentalAdministration once daily at approximately the same time of day, with or without food
Receives: Drug: ACP-204
PlaceboPlacebo comparatorAdministration once daily at approximately the same time of day, with or without food
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B)

    The SAPS-H+D subscales are a measure of two psychotic symptoms: hallucinations and delusions. The SAPS-H+D total score is the sum of the scores of the Hallucinations and Delusions subscales. The hallucinations domain score (SAPS-H) is the sum of the 7 hallucinations item scores, and the delusions domain core (SAPS-D) is the sum of the 13 delusions item scores.

    Measured: From baseline to Week 6

Secondary outcomes (1)

  1. Clinical Global Impression-Severity in the ADP context (CGI-S-ADP) score

    The CGI-S scale is a clinician-rated, 7-point scale that is designed to rate the severity of the subject's symptoms at the time of assessment using the Investigator's judgment and past experience with subjects who have the same disorder. The CGI-S-ADP scale is the CGI-S scale applied in the ADP context, in which hallucinations and delusions are the symptoms of interest.

    Measured: Baseline to Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2023
  2. Study start14 Nov 2023
  3. Primary completionJan 2028 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,074 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06159673
Sponsor's protocol ID
ACP-204-006
Status last verified
Nov 2026
First submitted
27 Nov 2023
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing ACP-204 in people with Alzheimer's Disease Psychosis, run by ACADIA Pharmaceuticals Inc. at 155 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 155 sites in United States, Brazil, Serbia, Bulgaria, France and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christine Murphy (858-465-7480, cmurphy@acadia-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B) (time frame: From baseline to Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06159673.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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