MedTrace Logo

Dopaminergic Therapy for Frontotemporal Dementia Patients

NCT04937452 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-10-22

No results posted yet for this study

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. 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.

Conditions

  • Frontotemporal Dementia
  • Dementia
  • Aphasia, Primary Progressive
  • Pick Disease of the Brain
  • Brain Diseases
  • Central Nervous System Diseases
  • Nervous System Diseases
  • Neurocognitive Disorders
  • Mental Disorders
  • Neurodegenerative Diseases
  • Frontotemporal Lobar Degeneration
  • TDP-43 Proteinopathies
  • Proteostasis Deficiencies
  • Metabolic Disease
  • Aphasia
  • Speech Disorders
  • Language Disorders
  • Communication Disorders
  • Neurobehavioral Manifestations
  • Neurologic Manifestations

Interventions

DRUG

Rotigotine 4Mg/24Hrs Patch

Rotigotine 4 mg/24Hrs administration for 24 weeks

DRUG

Rotigotine 6Mg/24Hrs Patch

Rotigotine 6 mg/24Hrs administration for 24 weeks

DRUG

Placebo

Placebo administration for 24 weeks

Sponsors & Collaborators

  • Alzheimer's Drug Discovery Foundation

    collaborator OTHER

  • I.R.C.C.S. Fondazione Santa Lucia

    lead OTHER

Principal Investigators

  • Giacomo Koch, MD · Santa Lucia Foundation IRCCS

  • Martina Assogna, MD · Santa Lucia Foundation IRCCS

  • Alessandro Martorana, MD, PhD · University of Tor Vergata

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-03
Primary Completion
2023-12-30
Completion
2024-04-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04937452 on ClinicalTrials.gov