CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Extracts of citrus peels standardized in AUR and NAR (phytocomplex).dietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04744922
NCT04744922N/ACompleted

Clinical and Biological Effects of Citrus-phytochemicals in Subjective Cognitive Decline: a Pilot Randomized Controlled Trial.

IRCCS Centro San Giovanni di Dio Fatebenefratelli·interventional·Posted Feb 9, 2021·Updated Jun 18, 2023

In Brief

A clinical study evaluating Extracts of citrus peels standardized in AUR and NAR (phytocomplex). for Subjective Cognitive Decline. Completed, enrolled 80 participants across 1 site.

Detailed Summary

Subjective cognitive decline (SCD) is receiving increasing attention as a risk factor for incident dementia due to AD. SCD manifests prior to the onset of clinical impairment, and as such could serve as a potential target population for early intervention trials. The pathogenesis of AD is complex and involves a dysregulation of the neuroendocrine immune (NEI) system, a network of signaling molecules, such as neurotransmitters, hormones and cytokines. As a result, it may be unlikely that cognitive decline may be mitigated by drugs acting on a single specific target. Plant extracts acting at different levels of the NEI regulation could represent appealing therapeutic strategies for cognitive decline. Citrus-derived phytochemicals, like auraptene and naringenin, showed antioxidant, anti-inflammatory, and neuroprotective effects in preclinical studies of AD mouse models and preservation of cognition in elderly without cognitive impairment. This is a pilot randomized controlled trial to determine clinical and biological effects of Citrus-phytochemicals in individuals with SCD. Participants will be randomized to receive Citrus-phytochemicals standardized in auraptene and naringenin or placebo for 9 months. Cognitive tests and blood-based biological markers will be done at baseline and at the end of treatment as outcome measures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 9, 2021
Enrollment StartApr 7, 2021
Primary CompletionMay 15, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.4 years ago

Interventions

Extracts of citrus peels standardized in AUR and NAR (phytocomplex).dietary

One capsule a day for 9 months