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Dopaminergic Therapy for Frontotemporal Dementia Patients
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
Lead sponsor
Asset
Rotigotine
Listed sites
3
Recruiting sites
-
Enrollment
75
actual
Study population
Frontotemporal dementia
Key I/E criterion
•Age 40-80
Primary endpoint
•Frontal Assessment Battery (FAB)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. 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.
2. The patient is a man or a woman, aged from 40 to 80 years.
3. The patient has a Clinical Dementia Rating-FTD (CDR-FTD) total score of ≤2 at Screening.
4. The patient has not been treated with acetylcholinesterase inhibitor (AChEI), i.e., donepezil, galantamine, or rivastigmine, at the time of screening.
5. The patient is able to comply with the study procedures in the view of the investigator.
6. Evidence of frontotemporal hypometabolism at PET imaging.
7. Evidence of amyloid markers excluding Alzheimer's disease (cerebrospinal fluid Abeta/Tau dosages or amyloid PET imaging).
8. Signature and date of written ICF prior to entering in the study
9. 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
Exclusion criteria
1. 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)
2. 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.
3. The patients has history of seizure (with the exception of febrile seizures in childhood).
4. Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MR imaging.
5. 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).
Endpoints (16)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
3 endpointsClinical Dementia Rating scale-Frontotemporal dementia Sum Of Boxes (CDR-FTDSOB)
Time frame:24 weeks
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
descriptive
Mini Mental State Examination (MMSE)
Time frame:24 weeks
Mini-Mental State Examination (MMSE)
descriptive
Addenbrooke's Cognitive Examination Revised (ACE-R)
Time frame:24 weeks
descriptive
Executive function / language
2 endpointsFrontal Assessment Battery (FAB)
Time frame:24 weeks
descriptive
Screening for aphasia in Neurodegeneration (SAND) scale
Time frame:24 weeks
ratio, descriptive
Function / daily living
1 endpointAlzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time frame:24 weeks
ADCS-Activities of Daily Living (ADCS-ADL)
descriptive
Behavior / neuropsychiatric
1 endpointNeuropsychiatric Inventory (NPI) scale
Time frame:24 weeks
Neuropsychiatric Inventory (NPI)
descriptive
Neuroimaging
1 endpoint18F-FDG CT/PET
Time frame:24 weeks
change from baseline, improvement
Fluid / digital biomarkers
1 endpointTMS-EEG
Time frame:24 weeks
descriptive
Safety / tolerability / PK
1 endpointNature, frequency and severity of adverse events (AEs)
Time frame:24 weeks
event count, event
Other (unclassified)
6 endpointsFrontal Behavioural Inventory (FBI)
Time frame:24 weeks
descriptive
CGIC questionnaire
Time frame:24 weeks
descriptive
Long intracortical inhibition (LICI)
Time frame:24 weeks
descriptive
Short intracortical inhibition (SICI)
Time frame:24 weeks
descriptive
Short-Latency Afferent Inhibition (SAI)
Time frame:24 weeks
descriptive
Intermittent Theta Burst Stimulation (iTBS)
Time frame:24 weeks
descriptive
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID40809903via DERIVED
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.