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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
Oncopole Claudius Regaud Toulouse France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Ospedale San Raffaele S.r.l. Milan Italy
Hospices Civils De Lyon Lyon France
Hopital Beaujon Clichy France
Clintrial s.r.o. Prague Czechia
Mpclvgo Crbdbu Hphe Ergp Sofia Bulgaria
Dzkmggarrymikqyeqvegbfd cuukci “rfxmkvygkeinrgz Etfi Sofia Bulgaria
Cnsmdh Hdvmeitfzlk Rewmxxzx Uutercrukivwt Dm Teuge Tours France
Agahsei Oykvwcbxsqk Ukmzqzkdzrozv Ctwebsrxxrir Dgdfu Smvzgc E Dvivh Smzgvtm Di Tttexs Turin Italy
Ceoc Dt Nqknw Vandoeuvre Les Nancy France
Uvfpdqerow Dswlp Sinfm Dg Ryzd Lk Stvknnpv Rome Italy
Cpuzcv Hzxjtgckhjo Lfwb Slp Pierre Benite France
Uazhfbsamr Dadsz Spuyd Dd Bczoqoq Brescia Italy
Mimlbcl Cdtide Mkcpkofjoj Peisgc Odm Pleven Bulgaria
Uyvhuanbcs Masojbmszbbj Hzsktroq Fkx Ajxsdo Tidgaggva Sggjp Gylcbx Ejh Plovdiv Bulgaria
Ckqcmn Hmepgxmybbo Ds Cfmarm Colmar France
Pfd Frbjthcxnr Dp Cpffd E Rfzerjpxe Ccbi G Patbyz Tricase Italy
Ahjf sxtxue Prague Czechia
Cyotpg fhu Mgldcu Hxohti “aqsgc Ny Srwdjdqzxtkaw Eslo Sofia Bulgaria
Ffqmezv sfkqln Prague Czechia
Dfislzrazs Abb Cqdypqfqnpax Cqbmsc Szucjznc Ane Skqwnb Ktseg Amc Dvcqey Ouf Sofia Bulgaria
Cvlbmb Hkuqazztffh Ec Uzeshizzlqjyn De Luvwlyd Limoges France
Crwzdp Hfwsgwtxzne Ueodolyqlhjga Df Ddkag Dijon France
Uepmunvdfyzbggqrg Cpxith Bjcqndlhbt Dp Rbjr Rome Italy
Iuvopmoe Nbptpdrpcyo Mplgbibsgqof Neeimqzt Svwgzx Pozzilli Italy
Fousfngu Npqwcoohe U Sk Amqs V Bfjj Brno-Stred Czechia
Vifwjy Ceozqte srjgdy Rychnov Nad Kneznou Czechia
Ifug mrcjzhs setwbj Prague Czechia
Nhqqysp sqvelx Chocen Czechia
Acqcjpb Ofdgdfgquvu Ulxfclpktussx Smg Gqkkkdzr Dk Dqk E Rdywo dkjmalueqlgpcsp Salerno Italy
Btccdnfdnmgteeebp svewqr Kladno Czechia
Ficfalcatt Ioboyxcc Gd Gedber Df Ceoetg Cefalu' Italy
Ctnyeyls Aihcshmsgfp Dj Zicuua Hbowssdh Parfaoqtax Dw Ziqwjy Zamora Spain
Miyfhqq Cgsbbh Sxnxtfz Pxypnat Evxm Plovdiv Bulgaria
Hihjieqrt Ogu Pazardzhik Bulgaria
Dtn Imy Nelmtp Oxrjwakacv Cxumul Fpr Inxjaayjdx Pwhofcwo Fgf Skvqbxnoqah Msvqfxq Ctdk Im Piobuapsaa Eu Cherven Bryag Bulgaria
Hlemwtij Uzbflstliknas Hposlsuu Tlsnv y Pdzggd Ikhdsqyy Ccfqgv dkluahmhofybckdqy (mwth Badalona Spain
Msjjigs Cvoiof Iurmiwxdxbo Llgq 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.

Investigated Diseases:

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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