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

NCT04489017 | Completed Phase 2

• 1 other identifier: SPE.107
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Frontotemporal Dementia

Keywords

dopamine; frontal cortex; GABA

Outcome Measures

Primary Outcomes (1)

• Clinical Dementia Rating Scale- Frontotemporal dementia Sumo of Boxes (CDR-FTD-SOB)

  Battery to evaluate global disease severity

  24 weeks

Secondary Outcomes (10)

• Frontal Assessment Battery (FAB)

  24 weeks

• Screening for aphasia in Neurodegeneration (SAND)

  24 weeks

• Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)

  24 weeks

• Mini Mental State Examination (MMSE)

  24 weeks

• Long intracortical inhibition (LICI)

  24 weeks

Study Arms (2)

PEA-LUT

EXPERIMENTAL

PEA-LUT administration at the oral dosage of 700 mg x 2/day for 24 weeks

Dietary Supplement: PEA-LUT

PLACEBO

PLACEBO COMPARATOR

PLACEBO administration at the oral dosage of 700 mg x 2/day for 24 weeks

Dietary Supplement: PLACEBO

Interventions

PEA-LUT DIETARY_SUPPLEMENT

PEA-LUT administration at the oral dosage of 700 mg x 2/day

PEA-LUT

PLACEBO DIETARY_SUPPLEMENT

PLACEBO administration at the oral dosage of 700 mg x 2/day

PLACEBO

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 85 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).

You may not qualify if:

• 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)
• 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.
• The patients has history of seizure (with the exception of febrile seizures in childhood).
• 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).

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (2)

Giacomo Koch

Rome, 00179, Italy

Location

Santa Lucia Foundation

Rome, 00179, Italy

Location

MeSH Terms

Conditions

Frontotemporal Dementia

Condition Hierarchy (Ancestors)

Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: July 28, 2020
• Study Start: June 1, 2019
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: November 7, 2024

Record last verified: 2022-06

Locations

IT (2)