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CompletedPhase 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

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

Org study IDEudraCT 2019-002997-30
NCT IDNCT04937452

Timeline

Milestones

Study start2021-06-03actual
Study first posted2021-06-24actual
Primary completion2023-12-30actual
Study completion2024-04-01actual
Last update posted2024-10-22actual

Assets

Drug assets

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age40 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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

Other (unclassified)
6
Global cognition
3
Executive function / language
2
Function / daily living
1
Behavior / neuropsychiatric
1
Neuroimaging
1
Fluid / digital biomarkers
1
Safety / tolerability / PK
1

Global cognition

3 endpoints
Secondary/protocol endpoint

Clinical Dementia Rating scale-Frontotemporal dementia Sum Of Boxes (CDR-FTDSOB)

Time frame:24 weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Secondary/protocol endpoint

Mini Mental State Examination (MMSE)

Time frame:24 weeks

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

Addenbrooke's Cognitive Examination Revised (ACE-R)

Time frame:24 weeks

descriptive

Executive function / language

2 endpoints
Primary/protocol endpoint

Frontal Assessment Battery (FAB)

Time frame:24 weeks

descriptive

Secondary/protocol endpoint

Screening for aphasia in Neurodegeneration (SAND) scale

Time frame:24 weeks

ratio, descriptive

Function / daily living

1 endpoint
Secondary/protocol endpoint

Alzheimer'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 endpoint
Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI) scale

Time frame:24 weeks

Neuropsychiatric Inventory (NPI)

descriptive

Neuroimaging

1 endpoint
Secondary/protocol endpoint

18F-FDG CT/PET

Time frame:24 weeks

change from baseline, improvement

Fluid / digital biomarkers

1 endpoint
Secondary/protocol endpoint

TMS-EEG

Time frame:24 weeks

descriptive

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Nature, frequency and severity of adverse events (AEs)

Time frame:24 weeks

event count, event

Other (unclassified)

6 endpoints
Secondary/protocol endpoint/low confidence

Frontal Behavioural Inventory (FBI)

Time frame:24 weeks

descriptive

Secondary/protocol endpoint/low confidence

CGIC questionnaire

Time frame:24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Long intracortical inhibition (LICI)

Time frame:24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Short intracortical inhibition (SICI)

Time frame:24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Short-Latency Afferent Inhibition (SAI)

Time frame:24 weeks

descriptive

Secondary/protocol endpoint/low confidence

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.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.