Palmitoylethanolamide Combined With Luteoline in Frontotemporal Dementia Patients. A Randomized Controlled Trial

Frontotemporal Dementia Clinical Trial

— PEA-FTD  

Official title:

Palmitoylethanolamide Combined With Luteoline in Frontotemporal Dementia Patients. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04489017
• Other study ID #: SPE.107
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2022
• Source: I.R.C.C.S. Fondazione Santa Lucia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Frontotemporal dementia (FTD) is a devastating neurodegenerative disorder. It is the second most frequent cause of presenile neurodegenerative dementia in those less than 65 years of age. Currently, there is no effective pharmacological treatment to slow down the progression of FTD. Recently, it has been proposed that neuroinflammation could be involved in specific forms of FTD and that novel drugs targeting neuroinflammation could potentially be useful in FTD treatment. An available form of ultra-micronized PEA combined with luteoline (PEA-LUT) has gained attention for its proven anti-inflammatory and neuroprotective properties reported in neurodegenerative conditions related to FTD, such as Amyotrophic Lateral Sclerosis. The administration of PEA-LUT treatment may have a clinical impact in behavioural variant FTD (bv-FTD) patients. In particular, PEA-LUT treatment could be able to reduce behavioural disturbances, the more disabling symptoms in bv-FTD, with a related improvement of daily living activities of affected people. Moreover, a multimodal approach (cognitive/neurophysiological) can be used to assess the brain correlates related to the clinical improvement associated with PEA-LUT treatment, thus making remarkable strides in understanding how FTD affects the brain. Potentially the proposed project could provide a valid treatment for cognitive and behavioural dysfunction in FTD patients, with consistent impact for the National Health Systems and minimum cost for the patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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 85 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).

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).

Related Conditions & MeSH terms

• Aphasia, Primary Progressive
• Dementia
• Frontotemporal Dementia
• Pick Disease of the Brain

Intervention

Dietary Supplement:
• PEA-LUT
PEA-LUT administration at the oral dosage of 700 mg x 2/day
• PLACEBO
PLACEBO administration at the oral dosage of 700 mg x 2/day

Locations

Country	Name	City	State
Italy	Giacomo Koch	Rome
Italy	Santa Lucia Foundation	Rome

Sponsors (1)

Lead Sponsor	Collaborator
I.R.C.C.S. Fondazione Santa Lucia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Dementia Rating Scale- Frontotemporal dementia Sumo of Boxes (CDR-FTD-SOB)	Battery to evaluate global disease severity	24 weeks
Secondary	Frontal Assessment Battery (FAB)	Battery to evaluate executive functions	24 weeks
Secondary	Screening for aphasia in Neurodegeneration (SAND)	battery to evaluate language functions	24 weeks
Secondary	Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)	battery to evaluate activities of daily living	24 weeks
Secondary	Mini Mental State Examination (MMSE)	battery to evaluate global cognition	24 weeks
Secondary	Long intracortical inhibition (LICI)	TMS protocol to evaluate GABA(B)ergic transmission	24 weeks
Secondary	Sort intracortical inhibition (SICI)	TMS protocol to evaluate GABA(B)ergic transmission	24 weeks
Secondary	TMS-EEG	power in beta-gamma band to evaluate prefrontal cortical oscillatory activity	24 weeks
Secondary	Neuropsychiatric Inventory (NPI)	Battery to assess behavioral changes	24 weeks
Secondary	Addenbrooke's Cognitive Examination Revised (ACE-R)	Battery to evaluate global cognition changes	24 weeks
Secondary	Frontal Behavioural Inventory	Battery to evaluate behavioural functions	24 weeks