Study on ITI-1284 for Treating Psychosis in Alzheimer’s Patients

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What is this study about?

This clinical trial is focused on studying the treatment of psychosis associated with Alzheimer’s disease. The treatment being tested is a medication called ITI-1284, which is administered in tablet form. The study aims to evaluate how effective and safe this medication is for patients experiencing psychosis, which is a condition that can cause people to see or hear things that are not there or hold false beliefs.

The trial involves comparing the effects of ITI-1284 with a placebo, which looks like the real medication but does not contain the active ingredient. Participants in the study will take the medication once daily for a period of six weeks. During this time, researchers will monitor changes in the participants’ symptoms to determine how well the medication works in reducing the symptoms of psychosis.

The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The goal is to provide a clearer understanding of the potential benefits and safety of ITI-1284 for individuals with psychosis related to Alzheimer’s disease.

1 joining the study

Upon joining the study, you will be asked to provide consent. If you are able to understand the nature of the trial, you will sign the consent form. If not, a representative, such as a caregiver or family member, will provide consent on your behalf.

2 initial assessment

You will undergo an initial assessment to confirm eligibility. This includes checking your age, body mass index (BMI), and medical history related to Alzheimer’s disease and psychosis.

A series of tests will be conducted to confirm the presence of Alzheimer’s disease and associated psychosis. This may involve blood tests or reviewing past medical records.

3 baseline evaluation

A baseline evaluation will be conducted to assess your current condition. This includes scoring on the Behavioral Pathology in Alzheimer’s Disease Rating Scale (BEHAVE-AD) and the Clinical Global Impression-Severity (CGI-S) scale.

Your ability to perform daily activities and your mental state will be evaluated using the Mini-Mental State Examination (MMSE-2).

4 medication administration

You will be randomly assigned to receive either the study medication ITI-1284 or a placebo. The medication is administered as a sublingual tablet, which means it is placed under the tongue to dissolve.

The dosage will be flexible, and you will take the medication once daily for a duration of six weeks.

5 weekly assessments

Throughout the six-week period, you will have weekly assessments to monitor your response to the medication. This includes evaluating changes in your psychosis symptoms using the BEHAVE-AD scale.

Your overall condition will also be assessed using the CGI-S scale to track any improvements or changes.

6 end of study evaluation

At the end of the six-week period, a final evaluation will be conducted. This will involve a comprehensive assessment of your condition and any changes in symptoms.

The results from the BEHAVE-AD and CGI-S scales will be compared to the baseline to determine the efficacy of the treatment.

Who Can Join the Study?

The patient must be able to give consent to participate in the study. If the patient cannot give consent, a representative like a caregiver or family member can do it for them.
The patient must be a male or female who is at least 55 years old.
The patient must have a body mass index (BMI) between 18 and 40. BMI is a measure of body fat based on height and weight.
The patient must meet the clinical criteria for Alzheimer’s Disease (AD), confirmed by specific tests or historical medical records.
The patient must have symptoms of psychosis related to Alzheimer’s Disease. Psychosis includes symptoms like seeing or hearing things that are not there (hallucinations) or having false beliefs (delusions).
The patient must have had psychosis symptoms for at least one month, and these symptoms must be severe enough to affect daily activities.
The patient must score at least 2 on certain items of a test called the BEHAVE-AD, which measures psychosis symptoms.
The patient must have a score of 4 or higher on the Clinical Global Impression-Severity (CGI-S) scale, which measures the severity of the condition.
The patient must score between 6 and 24 on the Mini-Mental State Examination (MMSE-2), which tests mental abilities, and must be able to understand and answer questions.
The patient must live at home or in an assisted living or long-term care facility and be able to visit the clinic. If living at home, the patient must not live alone and must have been at their current location for at least 4 weeks before the study starts.

Who Cannot Join the Study?

Patients with any other type of psychosis not related to Alzheimer’s Disease cannot participate. Psychosis means having trouble telling what is real and what is not, which can include seeing or hearing things that others do not.
Patients who are not within the specified age range for the study cannot participate. The study is for adults only.
Patients who are not able to give their own consent to participate in the study cannot join. Consent means agreeing to take part in the study after understanding what it involves.
Patients who have any other serious medical conditions that might interfere with the study cannot participate. This means if you have another illness that could affect the study results, you may not be able to join.
Patients who are currently participating in another clinical trial cannot join this study. This is to ensure that the results are not affected by other treatments.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Poliklinika Vlatka Cavka d.o.o.	Zagreb	Croatia
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia	Bucharest	Romania

Other Sites

Site Name	City	Country
Klinika za psihijatriju Vrapce	Zagreb	Croatia
Hospital General Universitario De Albacete	Albacete	Spain
Mbpthkx Cunoyl Hhdh Eqbq	Sofia	Bulgaria
Utfyrlrfnot nuazpawrq Ld Pxxvreun Kgbmxk	Kosice	Slovakia
Uxjdhyzsga Ddpht Sqeyk Dz Bsasdtq	Brescia	Italy
Flgwgdwgk Pndf Lo Iedhqndatjckp Bkojovmqr Dak Hoallelt Uxhknmfizdyfn Lb Psb	Madrid	Spain
Kxc Zxazww	Zagreb	Croatia
Sbkbqwcs Dd Phvquvpnfv &drzgjtludepfexk Dfqtjtjweynhy Gaikns	Galati	Romania
Crcnoeg Mtwkslkbjh Sktk	Zaragoza	Spain
Pph Fevdhthxju Dm Cfrys E Rbgslszho Cjfj G Picywv	Tricase	Italy
Mmuuv Bqghb Djvjghvu nphlxchvobra aaevsckpqo sdjzek	Banska Bystrica	Slovakia
Cwzgtc fxu Mwgrri Hvmdnr “smzdy Nq Sicbqxptqcbzw Etpd	Sofia	Bulgaria
Ofroksv Bprpkvci Ntvsxrs Djhxhosoyck Cctage Oobllwbwvcf Ilz Kiljnur Hycpvki Kozmmprsm Gxhphievorny Ovobpix Amkysazfuvxjfm Sar z ooer	Scinawa	Poland
Cwwrkxh Zpmwfhc Rhntqi sznxoc	Bardejov	Slovakia
Pztvslzsqnu Sfhnwbbmtco Sjh z oakn	Bydgoszcz	Poland
Cbpco Dtde Sxpiil	Sibiu	Romania
Nnkuz Hfmfkd Cdwrxia spoinh	Brno	Czechia
Nckmvs ssgrog	Krompachy	Slovakia
Mrphizf Cwtwmb Shwutwyabh Buvgedgcsnb Oec	Blagoevgrad	Bulgaria
Cazqvpa Dy Nveqzexknqkkz Ixjefji Sswxqn	Melilla	Spain
Nxerkpzokp Sgr z oqmd svpli	Katowice	Poland
Eepmhg syhhvh	Kosice	Slovakia
Daoyjppzld Ale Cojqzldftoqy Ckkfgf Sqhjbnuv Aad Sptpoq Kdvbk Amy Drapbi Okk	Sofia	Bulgaria
Fcuhawvv Ninnrhfmo U Sr Abht V Boku	Brno-Stred	Czechia
Syetqwsp Utwcrizwkik Dm Uwsycft Muvnneg Ckxzytv Dmo Cvoee Dpdzdu	Bucharest	Romania
Urldojbqjc Hwskyhhk Bxcnqhngsj	Bratislava	Slovakia
Hbhbslin Ubzfgxrwgjcnz Dh Gxbhoo	Getafe	Spain
Ajmysme Umopc Lbocib Sfrie Sbpturygx N 8 Bbdowg	Vicenza	Italy
Utwsz &itsnmr Pyfvq Dos Suicwe Ktqojochm Ac	Stara Zagora	Bulgaria
Cvxkvl Fja Mxwser Hlrjco Vzmlrs Esrv	Vratsa	Bulgaria
Nfawhxt staxwh	Chocen	Czechia
Adblmcc Omqodoaiqqh Uboysltykjiqa Sko Gostphpl Dn Dep E Rsodt dlwgblflgxtrudz	Salerno	Italy
Cealbh Dz Emgtsgyh Sv Taybcrjxp A Tvmeygsmnbpklhouhfb Pajwqv Ttkajp Sqi Sginong	Bucharest	Romania
Fmmwdqbiun Inrkmfoc Gf Gkabdx Dg Crdlnx	Cefalu'	Italy
Cepesjom Ahwudalhirp Dc Zmrnbz Hskfuwhy Pqrfjjcjvl Do Zzseme	Zamora	Spain
Cfhogmd Ciljdri snzvrj	Vranov Nad Toplou	Slovakia
Dxh Ing Nsjxco Omdmortqac Chrbyv Fgm Ighzifekzx Peawwobz Fth Szgjhckrpka Mppswie Csdw Is Phrcmzwmcw Em	Cherven Bryag	Bulgaria
Mnahsqb Cjorwq Iafwnblsvws Lior	Sofia	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	23.06.2025
Croatia	Recruiting	23.06.2025
Czechia	Recruiting	23.06.2025
Italy	Recruiting	23.06.2025
Poland	Not recruiting	23.06.2025
Romania	Recruiting	23.06.2025
Slovakia	Recruiting	23.06.2025
Spain	Recruiting	23.06.2025

Trial locations

Investigated Drugs:

Iti-1284

ITI-1284 is a medication being studied for its potential to help people with Alzheimer’s disease who experience psychosis. Psychosis can include symptoms like seeing or hearing things that aren’t there or having beliefs that are not based in reality. This medication is taken once a day and is being tested to see if it can reduce these symptoms and improve the quality of life for patients. The study aims to find out if ITI-1284 is effective and safe for use in people with Alzheimer’s disease.

Investigated Diseases:

Psychosis associated with Alzheimer’s Disease – This condition involves the presence of psychotic symptoms in individuals diagnosed with Alzheimer’s Disease. It is characterized by delusions and hallucinations, which are false beliefs and sensory experiences that seem real but are not. These symptoms can lead to significant distress and may affect the individual’s behavior and interactions with others. The progression of psychosis in Alzheimer’s Disease can vary, with symptoms potentially becoming more frequent or severe over time. The condition is often linked to changes in the brain associated with Alzheimer’s, which affect memory, thinking, and behavior. As the disease progresses, these psychotic symptoms may become more pronounced, impacting the quality of life for both the individual and their caregivers.

Trial ID:

2024-513035-25-00

Protocol code:

ITI-1284-201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on ITI-1284 for Treating Psychosis in Alzheimer’s Patients

What is this study about?

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