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Study of ACP-204 for Treating Psychosis in Adults with Alzheimer’s Disease

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What is this study about?

This clinical trial is focused on studying a condition known as Alzheimer’s Disease Psychosis, which affects some individuals with Alzheimer’s disease, causing symptoms like hallucinations and delusions. The trial will test a new treatment called ACP-204, which is taken as a capsule. The purpose of the study is to evaluate how effective and safe ACP-204 is for treating these symptoms in adults.

Participants in the study will receive either ACP-204 or a placebo, which looks like the treatment but does not contain the active substance. The study will compare the effects of two different doses of ACP-204, 30 mg and 60 mg, to see how well they work in reducing symptoms. The treatment period will last up to six months, during which participants will take the medication orally, meaning by mouth.

The study aims to gather information on how ACP-204 affects the symptoms of Alzheimer’s Disease Psychosis over time. Participants will be monitored regularly to assess changes in their condition and to ensure their safety throughout the study. This research is important for understanding potential new treatments for managing symptoms associated with Alzheimer’s disease.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, living situation, and medical history related to Alzheimer’s disease and psychosis.

A study partner or caregiver is required to assist with study visits and ensure adherence to the study protocol.

2 initial assessment

An initial assessment is conducted to establish a baseline for the study. This includes evaluating psychotic symptoms and cognitive function using standardized scales.

A blood-based biomarker or other documented evidence is reviewed to confirm amyloid plaque deposition consistent with Alzheimer’s disease.

3 medication administration

Participants receive either ACP-204 or a placebo in capsule form, taken orally.

The dosage of ACP-204 is either 30 mg or 60 mg, administered as per the study protocol.

4 ongoing assessments

Regular assessments are conducted to monitor the efficacy and safety of the treatment. This includes evaluating changes in psychotic symptoms from baseline to Week 6 using the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales.

Secondary assessments may include other scales to measure overall improvement.

5 completion of study

The study is expected to continue until 2028, with participants completing all required visits and assessments as per the study schedule.

Final evaluations are conducted to assess the overall impact of the treatment on Alzheimer’s disease psychosis.

Who Can Join the Study?

  • The patient must be a male or female aged between 55 and 85 years old, living either in the community or in a care facility.
  • The patient should be able to attend all study visits with a study partner or caregiver.
  • If the patient is taking a medication called a cholinesterase inhibitor or memantine, the dose must be stable. These medications are often used to help with memory and thinking problems.
  • The patient must meet the clinical criteria for possible or probable Alzheimer’s Disease (AD) based on guidelines from the National Institute on Aging-Alzheimer Association (NIA-AA).
  • The patient must meet the revised criteria for psychosis in major or mild neurocognitive disorder as established by the International Psychogeriatrics Association (IPA). Psychosis refers to symptoms like seeing or hearing things that are not there.
  • The patient must have either a blood test or other evidence, like a brain scan or spinal fluid test, showing amyloid plaque buildup and changes in the brain that are consistent with Alzheimer’s Disease.
  • The patient must have had a previous brain scan, such as a magnetic resonance imaging (MRI) or computed tomography (CT) scan, that supports the diagnosis of Alzheimer’s Disease.
  • The patient must have a score between 6 and 24 on the Mini-Mental State Examination (MMSE), a test that measures thinking and memory skills.
  • The patient must have experienced psychotic symptoms for at least 2 months.
  • The patient must live in a stable place of residence with no plans to change living arrangements.
  • The patient must have a designated study partner or caregiver.

Who Cannot Join the Study?

  • Patients who do not have Alzheimer Disease psychosis cannot participate. This means the study is only for those who have this specific condition.
  • Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is for specific groups of people.
  • Both male and female patients can participate, but those who do not meet other criteria cannot join.
  • Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Centre Hospitalier De Colmar Colmar France
Centre Hospitalier Universitaire Rouen Rouen France
Medical Center Hera EOOD Sofia Bulgaria
Ospedale San Raffaele S.r.l. Milan Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Istituto Neurologico Mediterraneo Neuromed S.p.A. Pozzilli Italy
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Vestra Clinics s.r.o. Rychnov Nad Kneznou Czechia
INEP medical s.r.o. Prague Czechia
Neurohk s.r.o. Chocen Czechia
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona Salerno Italy
Fondazione Istituto G. Giglio Di Cafalu Cefalu' Italy
Complejo Asistencial De Zamora Hospital Provincial De Zamora Zamora Spain
Medical Center Spectar Plovdiv EOOD Plovdiv Bulgaria
Dr. Ivo Natsov Outpatient Clinic For Individual Practice For Specialized Medical Care In Psychiatry ET Cherven Bryag Bulgaria
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Hospices Civils De Lyon Lyon France
Universita Degli Studi Di Brescia Brescia Italy
Clintrial s.r.o. Prague Czechia
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD Sofia Bulgaria
Forbeli s.r.o. Prague Czechia
Medical Center Intermedica Ltd. Sofia Bulgaria
Aqnt sbdncy Prague Czechia
Chwaeb Hehbfizopbn Uhwatklezudiy Dg Dtbtr Dijon France
Cxqsms Hsrnrewvjaj Reihpbgd Upidjaihksqym Dp Tuqzh Tours France
Afahtqt Owjtwtaspgv Uopykxjcsxvqz Cymvbmiiavkw Dktfo Skjdyp E Djnso Svntzjm Df Tyjlqp Turin Italy
Caol Df Njvaz Vandoeuvre Les Nancy France
Bxgkkceruftyobcfu scngqg Kladno Czechia
Hjpfpwwtz Ovm Pazardzhik Bulgaria
Cwrcjw Hfhyfwbleov Eh Uvzdqpfrzvkgd Dq Lrpggyp Limoges France
Ufealivnum Ddesd Sfzze Dd Rphc Lg Seovuyuo Rome Italy
Htkgzemq Utkyqwmwutelj Hazmpehf Tmkel y Pszwso Iwgkeyea Coxeqv dhdncgtrowxpqdlkc (myzr Badalona Spain
Mhdnpps Cefzqr Mkfsjeqjgi Pqtaad Odn Pleven Bulgaria
Cmnmko fui Mkmjfj Hzeeby “acego Ni Sprnfixetjwgu Enrx Sofia Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
30.06.2024
Czechia Czechia
Not recruiting
30.06.2024
France France
Not recruiting
30.06.2024
Italy Italy
Not recruiting
30.06.2024
Spain Spain
Not recruiting
30.06.2024

Trial locations

Investigated drugs:

ACP-204 is a medication being studied for its potential to help adults with Alzheimer’s Disease who experience psychosis. The trial aims to understand how effective ACP-204 is in treating symptoms of psychosis in these patients. The study will also look at how the body responds to the medication to determine the best dose for treatment.

Alzheimer Disease Psychosis – This condition is a manifestation of Alzheimer’s disease characterized by symptoms such as hallucinations and delusions. It typically occurs in the later stages of Alzheimer’s, affecting the patient’s perception of reality. Hallucinations may involve seeing or hearing things that are not present, while delusions are false beliefs that are resistant to reason or contrary evidence. These symptoms can lead to increased distress and confusion for the individual. The progression of psychosis in Alzheimer’s can vary, with symptoms sometimes fluctuating in intensity. Understanding and managing these symptoms is crucial for improving the quality of life for those affected.

Trial ID:
2023-507325-42-00
NCT ID:
NCT06159673
Trial Phase:
Therapeutic exploratory (Phase II)

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