Skip to main content

Rotigotine

Dopaminergic therapy for frontotemporal dementia patients

Sponsor
I.R.C.C.S. Fondazione Santa Lucia
Phase
Drug
Rotigotine
Countries

Information about the drug that will be tested in the study

Name of the drug

Rotigotine (also named Neupro)

Administration

The drug will be administered via a transdermal patch placed on the skin.

Is the drug already on the market for another medical condition?

Yes - approved to treat Parkinson’s disease and restless legs syndrome in Europe and US.

Will all participants receive the same drug?
  • A transdermal patch of Rotigotine (4Mg/24Hrs)
  • A transdermal patch of Rotigotine (6Mg/24Hrs)
  • A transdermal patch of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect)

Neither the participant nor his/her doctor will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to assess the efficacy and safety of rotigotine in people with behavioural frontotemporal dementia.

How long will the treatment last?

6 months

What your involvement will entail?
  • During the study, participants will be asked to perform a Frontal Assessment Battery (FAB) test. It is a brief cognitive and behavioural test that incorporates several clinical assessments to screen for frontotemporal dementia
  • Participants will be asked to complete other tests that will assess their global cognition, executive functions, language, behavior and activities of daily living (i.e. tests or scales like NPI, FBI, CDR, MMSE, ADCS-ADL)
  • Participants will be asked to undertake brain scans (PET) to evaluate changes in brain metabolism
  • Complete some laboratory tests to evaluate the emergent adverse effects (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study).

Further information on the procedures, tests and number of visits can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

  • Be between 40 and 80 years old
  • Have a diagnosis of probable frontotemporal dementia behavioural variant according to the International consensus clinical diagnostic criteria described by Rascovsky et al., 2011.
  • Have a score above 2 in the Clinical Dementia Rating-FTD (CDR-FTD). This would suggest that the person has an impairment in their memory that is at a mild to moderate stage
  • Not be treated with acetylcholinesterase inhibitors as an approved anti-dementia medication (i.e. donepezil, rivastigmine, galantamine)
  • Have evidence of frontotemporal hypometabolism (PET scan)
  • Have evidence of amyloid markers (amyloid or Tau) excluding Alzheimer's disease in their brain (PET scan or lumbar punctures (CSF))
  • Women must be neither pregnant nor breastfeeding. Women of childbearing potential should be willing to use contraception.
Who cannot participate in the study?

People cannot take part in the study if they have or have experienced:

  • A neurodegenerative disorder of the central nervous system other than frontotemporal dementia (e.g. Alzheimer's disease, Lewy body dementia, Parkinson's disease, multiple sclerosis)
  • History of seizure (uncontrolled electrical disturbance in the brain)
  • Contraindications to MRI imaging (i.e. metal implants in the head, pacemaker, cochlear implants)
  • Treatment with any of the following medications: antipsychotics (i.e., Clozapine, Olanzapine), antiepileptics drugs (i.e., Carbamazepine, Primidone, Pregabalin, Gabapentin); antidepressants (i.e., Citalopram, Duolxetine, Paroxetine) within the past three months.

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.

Information for your doctor

Eudra CT Number

NCT04937452

Clinicaltrials.gov identifier

2019-002997-30

Study contact information

Caterina Motta

c.motta@hsantalucia.it

Link to full text

https://clinicaltrials.gov/ct2/show/NCT04937452

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on March 2022.

 
Acknowledgement

Alzheimer Europe's Clinical Trials Watch database was developed as part of the 2018 Work Plan which received funding under an operating grant from the European Union’s Health Programme (2014–2020).

Alzheimer Europe gratefully acknowledges the support of its corporate sponsors for the update and maintenance of the database.

Image
ctw_acknowledgment_2022-06