A Study of Fesoterodine and 5-[(1R,5R)-3-Azabicyclo[3.

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What is this study about?

This study is looking at a condition called Alzheimer’s Disease Psychosis, which can cause people with Alzheimer’s disease to experience hallucinations (seeing or hearing things that are not there) and delusions (believing things that are not true). The treatment being tested is called ML-007C-MA, which is given as a tablet taken by mouth. Some participants will receive ML-007C-MA while others will receive placebo. The purpose of the study is to find out if ML-007C-MA works better than placebo in reducing hallucinations and delusions in people with Alzheimer’s disease psychosis and to check if the treatment is safe.

During the study, participants will be randomly assigned to receive either ML-007C-MA or placebo for a treatment period of seven weeks. The maximum daily dose of ML-007C-MA that may be given is 210 milligrams. Participants will need to have a care partner who can provide information about their symptoms and help them follow the study requirements. The care partner must be in regular contact with the participant and will need to attend all study visits with them. Participants must have been living in the same home or care facility for at least six weeks before joining the study and are expected to stay there throughout the study period.

Throughout the study, doctors will measure changes in hallucinations and delusions using rating scales that assess the severity of these symptoms. They will compare scores from the beginning of the study to scores after seven weeks of treatment. The study will also look at whether the treatment helps with other symptoms such as agitation and aggression in some participants, and will measure how much distress caregivers experience related to the participant’s hallucinations and delusions. Participants must be between 55 and 90 years old and meet specific criteria related to their Alzheimer’s disease diagnosis and the presence of psychotic symptoms for at least two months. A brain scan using MRI or CT must be available or completed during the screening period.

1 Initial assessment and baseline evaluation

At the beginning of the study, your symptoms will be assessed using a scoring system called NPI-C H+D, which measures hallucinations (seeing or hearing things that are not there) and delusions (false beliefs). This score must be 6 or higher for you to continue in the study.

Your doctor will evaluate the severity of your hallucinations and delusions using a scale called CGI-S (Clinical Global Impression – Severity). Your score must be 4 or higher, indicating at least moderate symptoms.

Your cognitive function will be tested using the MMSE (Mini-Mental State Examination), which assesses memory and thinking abilities. Your score should be between 6 and 26.

A brain scan (either MRI or CT scan) will be reviewed. If you do not have a recent scan from the past 3 years, one will be performed during this screening period.

Your body mass index (BMI) will be measured to ensure it is at least 18.5.

If you are taking any medications that are not allowed during the study, these will need to be stopped before you can begin treatment. Your doctor will determine if stopping these medications is appropriate for your health.

Your care partner will be asked to provide consent to participate in the study, as they will need to accompany you to all visits and help monitor your symptoms and medication compliance.

2 Randomization and treatment assignment

You will be randomly assigned to receive either ML-007C-MA (the investigational medication) or placebo (an inactive tablet that looks identical to the medication but contains no active ingredients).

Neither you nor your doctor will know which treatment you are receiving. This is called a double-blind study design.

The medication will be provided as a tablet for oral use (taken by mouth).

3 Treatment period

You will take the assigned medication daily for 7 weeks.

The exact dosage and frequency of administration will be determined by the study protocol and your doctor’s instructions.

Your care partner will help ensure that you take the medication as prescribed.

You will need to attend regular clinic visits during this period so that your doctor can monitor your symptoms and any side effects.

4 Ongoing assessments during treatment

Throughout the 7-week treatment period, your symptoms will be regularly assessed using the same scoring systems used at baseline.

The NPI-C H+D score will continue to measure changes in your hallucinations and delusions.

The CGI-S score will track the severity of your symptoms over time.

If you have symptoms of agitation or aggression (measured by a score of 4 or higher on the CGI-S agitation/aggression scale), these symptoms will also be monitored using the NPI-C A+A score.

Your care partner will be asked about the distress caused by your hallucinations and delusions, as this is also being measured in the study.

Your doctor will evaluate your overall improvement or worsening using the CGI-C (Clinical Global Impression – Change) scale.

5 Final assessment at week 7

At the end of the 7-week treatment period, a final evaluation will be conducted.

Your NPI-C H+D score will be compared to your baseline score to determine if there has been improvement in your hallucinations and delusions.

Your CGI-S and CGI-C scores will be recorded to assess the severity and change in your symptoms.

If applicable, changes in your agitation and aggression symptoms will also be evaluated.

The distress experienced by your care partner due to your symptoms will be reassessed.

The study will determine if you are a responder to treatment, which is defined as a reduction of at least 30% in your NPI-C H+D score compared to baseline.

Who Can Join the Study?

You must be between 55 and 90 years old at the time of signing the consent form
You must have hallucinations (seeing or hearing things that are not there) and delusions (strong false beliefs) related to Alzheimer’s disease
You must have had these psychotic symptoms (hallucinations or delusions) for at least 2 months before entering the study
You must meet the medical criteria for Possible or Probable Alzheimer’s disease based on established guidelines
Your score on a test called the MMSE (a test that measures memory and thinking abilities) must be between 6 and 26
Your score on a scale that measures the severity of hallucinations and delusions must be 4 or higher at two different visits
You must have a specific score on another scale called the NPI-C that shows moderate to severe hallucinations or delusions
You must have had a brain scan (either MRI or CT) within the past 3 years after your memory problems started, or be willing to have one done during the screening period
Your body mass index (a measure of body weight relative to height) must be 18.5 or higher
You must be willing to stop taking certain medications that are not allowed in the study before starting treatment
You must have a care partner who sees you regularly, can report on your symptoms, speaks the local language, agrees to attend all study visits with you, and signs a consent form
You must be able to communicate well enough to complete study procedures, with help from hearing aids or glasses if needed
You must be willing to attend all clinic visits, using a wheelchair or other walking aid if necessary
You must have lived at the same home or care facility for at least 6 weeks before the study and plan to stay there throughout the study
You must be willing and able to sign a consent form, or if you cannot make this decision yourself, a legally authorized representative (someone legally allowed to make decisions for you) must sign the consent form and you must agree to participate
If you are a woman who can become pregnant or a man who is sexually active with a woman who can become pregnant, you must be willing to use birth control during the study and follow restrictions about donating eggs or sperm

Who Cannot Join the Study?

The study information provided does not contain specific exclusion criteria, which are reasons why a patient cannot participate in the clinical trial
Without detailed exclusion criteria listed in the source data, it is not possible to provide specific conditions or situations that would prevent participation in this study
Typically, exclusion criteria may include things like other medical conditions, certain medications being taken, or specific test results, but these details are not available in the provided information
To learn about specific reasons why you might not be able to join this trial, you would need to access the complete study documentation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia	Bucharest	Romania
Oncopole Claudius Regaud	Toulouse	France
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Praglandia s.r.o.	Prague	Czechia
Neurohk s.r.o.	Chocen	Czechia
University Multiprofessional Hospital For Active Treatment Kanev AD	Ruse	Bulgaria
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
Crystal Comfort s.r.o.	Vranov Nad Toplou	Slovakia
CNS Saude Lda.	Torres Vedras	Portugal
Pia Fondazione Di Culto E Religione Card G Panico	Tricase	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila	Bucharest	Romania
University Of Pecs	Pecs	Hungary
Gyongyosi Bugat Pal Korhaz	Gyongyos	Hungary
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD	Sofia	Bulgaria
Les Hopitaux Nord-Ouest	Villefranche sur Saône	France
Institutul De Psihiatrie Socola Lasi	Iasi	Romania
NZOZ NEUROMED M. I M. NASTAJ Sp. P.	Lublin	Poland
Insula Badania Sp. z o.o.	Warsaw	Poland
Ddrxyttttl Aco Cmqeqlfzds Crawjd 1 Pgdxrw Eizy	Pernik	Bulgaria
Pgcvnfgpgs Kvfl	Pecs	Hungary
Smeukfp Upmduokpptdhd W Ksmtkhvu	Cracow	Poland
Ubebbljodtzvcs Ckbxqsp Kklxsxtle	Gdansk	Poland
Kslcbdtoj shbykw	Dubnica nad Váhom	Slovakia
Hjccvxie Uakolkcjdprumt Suheehqjdy &lvgsye Hydxacv dp Hcatsidfvlf	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	31.10.2025
Czechia	Recruiting	31.10.2025
France	Recruiting	31.10.2025
Hungary	Recruiting	31.10.2025
Italy	Recruiting	31.10.2025
Poland	Recruiting	31.10.2025
Portugal	Recruiting	31.10.2025
Romania	Recruiting	31.10.2025
Slovakia	Recruiting	31.10.2025

Trial locations

Investigated drugs:

5-[(1R,5R)-3-AZABICYCLO[3.1.0]HEXAN-1-YL]-3-METHYL-1,2,4-OXADIAZOLE

ML-007C-MA is an investigational medication being studied for the treatment of hallucinations and delusions in people with Alzheimer’s disease psychosis. Hallucinations are when a person sees, hears, or senses things that are not really there, and delusions are false beliefs that a person holds despite evidence to the contrary. This medication is being tested to see if it can help reduce these symptoms in patients with Alzheimer’s disease.

Placebo is an inactive substance that looks like the real medication but contains no active ingredients. It is used in this study to compare against the actual medication to help researchers understand whether the medication being tested is truly effective.

Investigated diseases:

Dementia of the Alzheimer's type with delusions

Alzheimer’s Disease Psychosis – Alzheimer’s Disease Psychosis is a condition that occurs in people who have Alzheimer’s disease and develop additional psychiatric symptoms. The main features of this condition include hallucinations, where a person sees, hears, or senses things that are not really there, and delusions, which are false beliefs that the person holds despite evidence to the contrary. These symptoms appear as Alzheimer’s disease progresses and the brain continues to deteriorate. The hallucinations and delusions can cause significant distress to both the person experiencing them and their caregivers. As the underlying Alzheimer’s disease worsens over time, these psychotic symptoms may become more frequent or intense. This condition represents a more advanced stage of Alzheimer’s disease where cognitive decline is accompanied by changes in perception and thinking.

Trial ID:

2024-519820-26-00

Protocol code:

ML-007C-MA-221

NCT ID:

NCT06887192

Trial Phase:

Therapeutic exploratory (Phase II)

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A Study of Fesoterodine and 5-[(1R,5R)-3-Azabicyclo[3.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?