Frontotemporal DementiaPhase 2NCT04937452
Dopaminergic Therapy for Frontotemporal Dementia Patients
A Phase 2 study testing Rotigotine 4Mg/24Hrs Patch and Rotigotine 6Mg/24Hrs Patch in people with Frontotemporal Dementia and Dementia, run by I.R.C.C.S. Fondazione Santa Lucia at 3 sites in Italy.
Trial summary
This is a phase IIa 24-week randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy and safety of Rotigotine (RTG) transdermal administration at the dosage of 4 mg or 6 mg per day versus Placebo (PLC) in newly diagnosed behavioural Frontotemporal Dementia (bvFTD) patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Frontotemporal Dementia, Dementia, Aphasia, Primary Progressive
- What is being tested?
- Rotigotine 4Mg/24Hrs Patch and Rotigotine 6Mg/24Hrs Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 3 sitesItaly
- Study dates
- 3 Jun 2021to 1 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has a diagnosis of probable Frontotemporal dementia behavioural variant (bv-FTD) based on the International consensus clinical diagnostic criteria described by Rascovsky et al., 2011.
- The patient is a man or a woman, aged from 40 to 80 years.
- The patient has a Clinical Dementia Rating-FTD (CDR-FTD) total score of ≤2 at Screening.
- The patient has not been treated with acetylcholinesterase inhibitor (AChEI), i.e., donepezil, galantamine, or rivastigmine, at the time of screening.
- The patient is able to comply with the study procedures in the view of the investigator.
- Evidence of frontotemporal hypometabolism at PET imaging.
Show all 9Show fewer
- Evidence of amyloid markers excluding Alzheimer's disease (cerebrospinal fluid Abeta/Tau dosages or amyloid PET imaging).
- Signature and date of written ICF prior to entering in the study
- Female patient must be neither pregnant nor breastfeeding. Women of childbearing potential should be willing to use contraception while receiving Rotigotine and for six months after its last assumption
Who cannot join
- Significant neurodegenerative disorder of the central nervous system other than FTD e.g., Alzheimer's disease, Lewy body dementia, Parkinson's disease, multiple sclerosis, progressive supranuclear palsy, normal pressure hydrocephalus, Huntington's disease, any condition directly or indirectly caused by Transmissible Spongiform Encephalopathy (TSE), Creutzfeldt-Jakob Disease (CJD), variant Creutzfeldt-Jakob Disease (vCJD), or new variant Creutzfeldt-Jakob Disease (nvCJD)
- Significant intracranial focal or vascular pathology seen on brain MRI scan within a maximum of 6 months before Baseline leading to a diagnosis other than probable FTD.
- The patients has history of seizure (with the exception of febrile seizures in childhood).
- Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MR imaging.
- Treatment currently or within 3 months before Baseline with any of the following medications: Typical and Atypical antipsychotics (i.e., Clozapine, Olanzapine); Antiepileptics drugs (i.e., Carbamazepine, Primidone, Pregabalin, Gabapentin); Antidepressants (i.e., Citalopram, Duolxetine, Paroxetine).
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Department of Neurology, University of Brescia
Brescia
Giacomo Koch
Rome, <None>, 00179
Santa Lucia Foundation
Rome, 00179
About this study
Official title: Dopaminergic Therapy for Frontotemporal Dementia Patients: an Interventional, Multi-site, Randomized, Double-blind, Placebo-controlled Study on the Efficacy and Safety of RTG Treatment in Patients with Behavioral FTD
This is a phase IIa 24-week randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy and safety of Rotigotine (RTG) transdermal administration at the dosage of 4 mg or 6 mg per day versus Placebo (PLC) in newly diagnosed behavioural Frontotemporal Dementia (bvFTD) patients. 75 patients with a diagnosis of probable bvFTD will be randomly allocated to the 3 treatment arms (RTG 4mg/day, RTG 6mg/day or PLC), with 25 patients per group. Clinical and neurophysiological measurements and brain metabolism via FDG-PET will be collected before and after drug administration.
Read the detailed description
The current study has the ambition to provide the first-time evidence of the clinical impact, at cognitive and behavioral level, of a dopamine-based treatment in newly diagnosed bvFTD patients.
To evaluate the cognitive and behavioral effects of RTG administration, the investigators will employ a battery of tests assessing global cognition, executive functions, language and behavior.
The battery will include: Neuropsychiatric Inventory (NPI) and Frontal Behavioral Inventory (FBI) to evaluate behavior, Clinical Dementia Rating Scale-Frontotemporal Dementia Sum Of Boxes (CDR-FTD SOB) to evaluate global disease severity, Frontal Assessment Battery (FAB) to evaluate frontal functions, Screening for aphasia in Neurodegeneration (SAND) to evaluate language functions, Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) to evaluate activities of daily living, the Addenbrooke's Cognitive Examination Revised (ACE-R) to evaluate global cognition.
To evaluate changes in brain metabolism the investigators will perform 2 FDG-PET scans before starting the treatment and at the end of week 24.
Neurophysiological investigations will be performed to identify quantifiable biomarkers underlying the effects induced by dopamine agonist on the bvFTD brain. In particular, the investigators will use multimodal neurophysiological tools based on TMS-EMG and TMS-EEG. More specifically, different paired-pulse TMS protocols will be used to evaluate in vivo the activity of different intracortical circuits, such as short intracortical inhibition (SICI), reflecting GABA(A)-ergic neurotransmission; long intracortical inhibition (LICI), evaluating GABA(B)-ergic neurotransmission; short afferent inhibition (SAI) evaluating cholinergic neurotransmission and intermittent theta burst stimulation (iTBS) probing cortical plasticity mechanisms, such as long- term potentiation (LTP). The effects of these protocols will be evaluated by means of motor-evoked potentials, recordable with EMG. TMS-EEG will be used to measure the effects of RTG on frontal and parieto-temporal cortical activity, in terms of cortical excitability, oscillatory activity and connectivity. The investigators will evaluate the effects of the DA drug on brain activity and plasticity by analyzing MEPs and TEPs before and after the treatment. The investigators expect to find modulations in the high EEG frequencies (beta and gamma oscillatory activities) and/or in the indexes of cortical reactivity and plasticity (amplitude of TEPs and MEPs) that correlate with improvement in clinical assessment.
- Conditions
- Frontotemporal Dementia, Dementia, Aphasia, Primary Progressive, Pick Disease of the Brain, Brain Diseases, Central Nervous System Diseases
- Being tested
- Rotigotine 4Mg/24Hrs Patch, Rotigotine 6Mg/24Hrs Patch, Placebo
- Keywords
- dopamine, frontal cortex, FTD, Rotigotine
- Medical subject headings
- Frontotemporal Dementia, Dementia, Aphasia, Primary Progressive, Pick Disease of the Brain, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotigotine 4Mg/24Hrs PatchDrug
Also called Neupro
Rotigotine 4 mg/24Hrs administration for 24 weeks
Rotigotine 6Mg/24Hrs PatchDrug
Also called Neupro
Rotigotine 6 mg/24Hrs administration for 24 weeks
PlaceboDrug
Placebo administration for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rotigotine 4 mg | Experimental | Rotigotine 4 mg/24 hours transdermal patch administration Receives: Drug: Rotigotine 4Mg/24Hrs Patch |
| Rotigotine 6 mg | Experimental | Rotigotine 6 mg/24 hours transdermal patch administration Receives: Drug: Rotigotine 6Mg/24Hrs Patch |
| Placebo | Placebo comparator | Placebo transdermal patch administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frontal Assessment Battery (FAB)
Battery to evaluate executive functions. The scores range from 0-18 with a higher score meaning less cognitive impairment.
Measured: 24 weeks
Secondary outcomes (15)
Neuropsychiatric Inventory (NPI) scale
Battery to assess behavioral changes. The scores range from 0-144 with a higher score meaning more severe behavioural disturbances.
Measured: 24 weeks
Frontal Behavioural Inventory (FBI)
Battery to assess behavioral changes. The scores range from 0-72 with a higher score meaning more severe behavioural disturbances.
Measured: 24 weeks
Clinical Dementia Rating scale-Frontotemporal dementia Sum Of Boxes (CDR-FTDSOB)
Battery to evaluate global disease severity. The scores range from 0-24 with a higher score meaning higher disease severity.
Measured: 24 weeks
Screening for aphasia in Neurodegeneration (SAND) scale
Battery to evaluate language functions. The scores range from 0-84 with a higher score meaning less severe language deficits.
Measured: 24 weeks
Mini Mental State Examination (MMSE)
battery to evaluate global cognition. The scores range from 0-30 with a higher score meaning less cognitive impairment.
Measured: 24 weeks
Addenbrooke's Cognitive Examination Revised (ACE-R)
battery to evaluate global cognition. The scores range from 0-100 with a higher score meaning less cognitive impairment.
Measured: 24 weeks
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
battery to evaluate activities of daily living. The scores range from 0-78 with lower scores indicating more severe functional impairment.
Measured: 24 weeks
CGIC questionnaire
questionnaire to evaluate clinically meaningful change
Measured: 24 weeks
18F-FDG CT/PET
Change in brain glucose metabolism will be measured via FDG-PET
Measured: 24 weeks
Long intracortical inhibition (LICI)
TMS protocol to evaluate GABA(B)ergic transmission
Measured: 24 weeks
Short intracortical inhibition (SICI)
TMS protocol to evaluate GABA(B)ergic transmission
Measured: 24 weeks
Short-Latency Afferent Inhibition (SAI)
TMS protocol to evaluate cholinergic transmission
Measured: 24 weeks
Intermittent Theta Burst Stimulation (iTBS)
TMS protocol to evaluate cortical plasticity
Measured: 24 weeks
TMS-EEG
power in beta-gamma band to evaluate prefrontal cortical oscillatory activity
Measured: 24 weeks
Nature, frequency and severity of adverse events (AEs)
To assess the safety and tolerability
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start3 Jun 2021
- Primary completion30 Dec 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frontotemporal DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Drug Discovery Foundation
- Responsible party
- Principal investigator, Giacomo Koch, I.R.C.C.S. Fondazione Santa Lucia
- Investigators
- Giacomo Koch, MD, Principal investigator, Santa Lucia Foundation IRCCSMartina Assogna, MD, Study director, Santa Lucia Foundation IRCCSAlessandro Martorana, MD, PhD, Study chair, University of Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937452
- Sponsor's protocol ID
- EudraCT 2019-002997-30
- Status last verified
- Jul 2022
- First submitted
- 16 Jun 2021
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Koch G, Assogna M, Gadola Y, Alberici A, Di Lorenzo F, Bonni S, Borghi I, Cerulli Irelli E, Mencarelli L, Maiella M, Esposito R, Casula EP, Pezzopane V, D'Acunto A, Candeo F, Ferraresi M, Guerrera G, Battistini L, Premi E, Bracca V, Lucchini S, Bertagna F, Romano P, Ludovici A, Daniele A, Motta C, Ferrari C, Martorana A, Borroni B. Safety and efficacy of rotigotine in patients with frontotemporal dementia: a phase 2, double-blind, randomized, placebo-controlled, multicenter trial. Lancet Reg Health Eur. 2025 Aug 5;57:101409. doi: 10.1016/j.lanepe.2025.101409. eCollection 2025 Oct.
PubMed 40809903
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopaminergic Therapy for Frontotemporal Dementia Patients: an Interventional, Multi-site, Randomized, Double-blind, Placebo-controlled Study on the Efficacy and Safety of RTG Treatment in Patients with Behavioral FTD
- ClinicalTrials.gov ID
- NCT04937452
- Acronym / sponsor ID
- EudraCT 2019-002997-30
- Conditions
- Frontotemporal Dementia, Dementia, Aphasia, Primary Progressive, Pick Disease of the Brain, Brain Diseases, Central Nervous System Diseases
- Keywords
- dopamine, frontal cortex, FTD, Rotigotine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Collaborators
- Alzheimer's Drug Discovery Foundation
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase IIa 24-week randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy and safety of Rotigotine (RTG) transdermal administration at the dosage of 4 mg or 6 mg per day versus Placebo (PLC) in newly diagnosed behavioural Frontotemporal Dementia (bvFTD) patients. 75 patients with a diagnosis of probable bvFTD will be randomly allocated to the 3 treatment arms (RTG 4mg/day, RTG 6mg/day or PLC), with 25 patients per group. Clinical and neurophysiological measurements and brain metabolism via FDG-PET will be collected before and after drug administration.
Detailed description
The current study has the ambition to provide the first-time evidence of the clinical impact, at cognitive and behavioral level, of a dopamine-based treatment in newly diagnosed bvFTD patients.
To evaluate the cognitive and behavioral effects of RTG administration, the investigators will employ a battery of tests assessing global cognition, executive functions, language and behavior.
The battery will include: Neuropsychiatric Inventory (NPI) and Frontal Behavioral Inventory (FBI) to evaluate behavior, Clinical Dementia Rating Scale-Frontotemporal Dementia Sum Of Boxes (CDR-FTD SOB) to evaluate global disease severity, Frontal Assessment Battery (FAB) to evaluate frontal functions, Screening for aphasia in Neurodegeneration (SAND) to evaluate language functions, Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) to evaluate activities of daily living, the Addenbrooke's Cognitive Examination Revised (ACE-R) to evaluate global cognition.
To evaluate changes in brain metabolism the investigators will perform 2 FDG-PET scans before starting the treatment and at the end of week 24.
Neurophysiological investigations will be performed to identify quantifiable biomarkers underlying the effects induced by dopamine agonist on the bvFTD brain. In particular, the investigators will use multimodal neurophysiological tools based on TMS-EMG and TMS-EEG. More specifically, different paired-pulse TMS protocols will be used to evaluate in vivo the activity of different intracortical circuits, such as short intracortical inhibition (SICI), reflecting GABA(A)-ergic neurotransmission; long intracortical inhibition (LICI), evaluating GABA(B)-ergic neurotransmission; short afferent inhibition (SAI) evaluating cholinergic neurotransmission and intermittent theta burst stimulation (iTBS) probing cortical plasticity mechanisms, such as long- term potentiation (LTP). The effects of these protocols will be evaluated by means of motor-evoked potentials, recordable with EMG. TMS-EEG will be used to measure the effects of RTG on frontal and parieto-temporal cortical activity, in terms of cortical excitability, oscillatory activity and connectivity. The investigators will evaluate the effects of the DA drug on brain activity and plasticity by analyzing MEPs and TEPs before and after the treatment. The investigators expect to find modulations in the high EEG frequencies (beta and gamma oscillatory activities) and/or in the indexes of cortical reactivity and plasticity (amplitude of TEPs and MEPs) that correlate with improvement in clinical assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rotigotine 4 mg | Experimental | Drug: Rotigotine 4Mg/24Hrs PatchRotigotine 4 mg/24 hours transdermal patch administration |
| Rotigotine 6 mg | Experimental | Drug: Rotigotine 6Mg/24Hrs PatchRotigotine 6 mg/24 hours transdermal patch administration |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo transdermal patch administration |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient has a diagnosis of probable Frontotemporal dementia behavioural variant (bv-FTD) based on the International consensus clinical diagnostic criteria described by Rascovsky et al., 2011.
- The patient is a man or a woman, aged from 40 to 80 years.
- The patient has a Clinical Dementia Rating-FTD (CDR-FTD) total score of ≤2 at Screening.
- The patient has not been treated with acetylcholinesterase inhibitor (AChEI), i.e., donepezil, galantamine, or rivastigmine, at the time of screening.
- The patient is able to comply with the study procedures in the view of the investigator.
Key exclusion criteria (5 listed)
- Significant neurodegenerative disorder of the central nervous system other than FTD e.g., Alzheimer's disease, Lewy body dementia, Parkinson's disease, multiple sclerosis, progressive supranuclear palsy, normal pressure hydrocephalus, Huntington's disease, any condition directly or indirectly caused by Transmissible Spongiform Encephalopathy (TSE), Creutzfeldt-Jakob Disease (CJD), variant Creutzfeldt-Jakob Disease (vCJD), or new variant Creutzfeldt-Jakob Disease (nvCJD)
- Significant intracranial focal or vascular pathology seen on brain MRI scan within a maximum of 6 months before Baseline leading to a diagnosis other than probable FTD.
- The patients has history of seizure (with the exception of febrile seizures in childhood).
- Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MR imaging.
- Treatment currently or within 3 months before Baseline with any of the following medications: Typical and Atypical antipsychotics (i.e., Clozapine, Olanzapine); Antiepileptics drugs (i.e., Carbamazepine, Primidone, Pregabalin, Gabapentin); Antidepressants (i.e., Citalopram, Duolxetine, Paroxetine).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotigotine 4Mg/24Hrs PatchAlso: NeuproRotigotine 4 mg/24Hrs administration for 24 weeks | Drug | Rotigotine 4 mg |
| Rotigotine 6Mg/24Hrs PatchAlso: NeuproRotigotine 6 mg/24Hrs administration for 24 weeks | Drug | Rotigotine 6 mg |
| PlaceboPlacebo administration for 24 weeks | Drug | Placebo |
Primary outcome
Frontal Assessment Battery (FAB)
Time frame: 24 weeks
Battery to evaluate executive functions. The scores range from 0-18 with a higher score meaning less cognitive impairment.
15 secondary outcomes
Neuropsychiatric Inventory (NPI) scale
Time frame: 24 weeks
Frontal Behavioural Inventory (FBI)
Time frame: 24 weeks
Clinical Dementia Rating scale-Frontotemporal dementia Sum Of Boxes (CDR-FTDSOB)
Time frame: 24 weeks
Screening for aphasia in Neurodegeneration (SAND) scale
Time frame: 24 weeks
Mini Mental State Examination (MMSE)
Time frame: 24 weeks
Addenbrooke's Cognitive Examination Revised (ACE-R)
Time frame: 24 weeks
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time frame: 24 weeks
CGIC questionnaire
Time frame: 24 weeks
18F-FDG CT/PET
Time frame: 24 weeks
Long intracortical inhibition (LICI)
Time frame: 24 weeks
Short intracortical inhibition (SICI)
Time frame: 24 weeks
Short-Latency Afferent Inhibition (SAI)
Time frame: 24 weeks
Intermittent Theta Burst Stimulation (iTBS)
Time frame: 24 weeks
TMS-EEG
Time frame: 24 weeks
Nature, frequency and severity of adverse events (AEs)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Derived from this study: PubMed 40809903Koch G, Assogna M, Gadola Y, Alberici A, Di Lorenzo F, Bonni S, Borghi I, Cerulli Irelli E, Mencarelli L, Maiella M, Esposito R, Casula EP, Pezzopane V, D'Acunto A, Candeo F, Ferraresi M, Guerrera G, Battistini L, Premi E, Bracca V, Lucchini S, Bertagna F, Romano P, Ludovici A, Daniele A, Motta C, Ferrari C, Martorana A, Borroni B. Safety and efficacy of rotigotine in patients with frontotemporal dementia: a phase 2, double-blind, randomized, placebo-controlled, multicenter trial. Lancet Reg Health Eur. 2025 Aug 5;57:101409. doi: 10.1016/j.lanepe.2025.101409. eCollection 2025 Oct.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giacomo Koch, MD principal investigator
Santa Lucia Foundation IRCCS
Martina Assogna, MD study director
Santa Lucia Foundation IRCCS
Alessandro Martorana, MD, PhD study chair
University of Tor Vergata
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rotigotine 4Mg/24Hrs Patch and Rotigotine 6Mg/24Hrs Patch in people with Frontotemporal Dementia and Dementia, run by I.R.C.C.S. Fondazione Santa Lucia at 3 sites in Italy.
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 9 inclusion and 5 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: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frontal Assessment Battery (FAB) (time frame: 24 weeks). 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 NCT04937452, which also lists 1 linked publication.
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 22 Oct 2024.