NCT04937452CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 22 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (actual)
- First submitted
- 16 Jun 2021
- Start date
- 3 Jun 2021
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Diseases
- Frontotemporal dementia
- NCT number
- NCT04937452
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 75
- From 3 Jun 2021 to the primary completion date, 30 Dec 2023
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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).
Other illness
- 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)
- The patients has history of seizure (with the exception of febrile seizures in childhood).
Who the study is looking for
- 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.
- 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
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurology, University of Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| Santa Lucia Foundation Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Giacomo Koch Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.