A Phase 2 interventional study of Rotigotine 4Mg/24Hrs Patch and Rotigotine 6Mg/24Hrs Patch in Frontotemporal Dementia, Dementia and Aphasia, Primary Progressive, sponsored by I.R.C.C.S. Fondazione Santa Lucia. Completed at 3 sites in Italy. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by I.R.C.C.S. Fondazione Santa Lucia · Phase 2, Interventional, and Treatment
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.
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.
208 studies on the registry are indexed under Frontotemporal Dementia; 72 are open to participants now.
This study's enrollment of 75 is above the median of 50 across 128 interventional studies indexed under Frontotemporal Dementia.
Browse Frontotemporal Dementia studies →I.R.C.C.S. Fondazione Santa Lucia is the lead sponsor of 56 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rotigotine 4 mg/24 hours transdermal patch administration
Drug: Rotigotine 4Mg/24Hrs Patch
Rotigotine 6 mg/24 hours transdermal patch administration
Drug: Rotigotine 6Mg/24Hrs Patch
Placebo transdermal patch administration
Drug: Placebo
Drug page: Rotigotine
Rotigotine 4 mg/24Hrs administration for 24 weeks
Also known as: Neupro
Drug page: Rotigotine
Rotigotine 6 mg/24Hrs administration for 24 weeks
Also known as: Neupro
Placebo administration for 24 weeks
Frontal Assessment Battery (FAB)
Battery to evaluate executive functions. The scores range from 0-18 with a higher score meaning less cognitive impairment.
Time frame: 24 weeks
Neuropsychiatric Inventory (NPI) scale
Battery to assess behavioral changes. The scores range from 0-144 with a higher score meaning more severe behavioural disturbances.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 weeks
CGIC questionnaire
questionnaire to evaluate clinically meaningful change
Time frame: 24 weeks
18F-FDG CT/PET
Change in brain glucose metabolism will be measured via FDG-PET
Time frame: 24 weeks
Long intracortical inhibition (LICI)
TMS protocol to evaluate GABA(B)ergic transmission
Time frame: 24 weeks
Short intracortical inhibition (SICI)
TMS protocol to evaluate GABA(B)ergic transmission
Time frame: 24 weeks
Short-Latency Afferent Inhibition (SAI)
TMS protocol to evaluate cholinergic transmission
Time frame: 24 weeks
Intermittent Theta Burst Stimulation (iTBS)
TMS protocol to evaluate cortical plasticity
Time frame: 24 weeks
TMS-EEG
power in beta-gamma band to evaluate prefrontal cortical oscillatory activity
Time frame: 24 weeks
Nature, frequency and severity of adverse events (AEs)
To assess the safety and tolerability
Time frame: 24 weeks
Ran from Jun 2021 to primary completion in Dec 2023, 30 months.
Of 19 phase 2 interventional studies under Frontotemporal Dementia, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 64. This study's 30 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rotigotine
I.R.C.C.S. Fondazione Santa Lucia