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Clinical Trials/NCT01707719
NCT01707719CompletedNot Applicable

Isolated Erythrocyte Membrane Susceptibility to Photo-oxidative Stress in Patients Affected by Alzheimer's Disease and Healthy Controls

Raffaele Antonelli Incalzi1 site in 1 country48 target enrollmentStarted: June 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
48
Locations
1
Primary Endpoint
Malondialdehyde assay

Study Overview

Brief Summary

High lipid peroxidation and altered antioxidant defenses have been frequently reported in Alzheimer's disease patients.

The purpose of this study is to investigate susceptibility to photo-oxidation of isolated erythrocyte membranes, in patients affected by Alzheimer's disease and age- and sex-matched, non demented subjects.

Detailed Description

The study hypothesis is that high lipid peroxidation and decreased antioxidant defenses characterize the natural history of Alzheimer's disease.

It will be evaluated the release of malondialdehyde (MDA) from ex-vivo photo-oxidized erythrocyte ghosts, through a very easy and convenient lab procedure for the preparation of erythrocyte membrane samples.

Isolated and purified red blood cell membranes will be in vitro exposed to oxidative stress by UV-B radiation. The extent of cell membrane damage will be quantified by the fluorometric determination of MDA.

Induction of oxidative stress through ultraviolet rays, unlike that obtained by chemical oxidizing agents, is fully controllable, since it produces effects only during irradiation. Moreover, using isolated erythrocyte membranes allows for a greater specificity in the evaluation of MDA produced, and reduces the amount of blood required for the assay.

A portion of the blood sample (500 µL) will be sent to the laboratory of Lipinutragen (spin-off of CNR- National Research Center Bologna, Italy) where an erythrocyte membrane lipidomic analysis will be performed for the characterization of membrane phospholipids, in order to determinate the different lipid components (saturated fatty acids, monounsaturated and polyunsaturated, trans fatty acids), each one characterized by a different oxidative reactivity.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Outpatients of both sexes diagnosed with Alzheimer's disease according to NINCDS-ADRDA criteria.
  • •Age and sex-matched elderly subjects without dementia.

Exclusion Criteria

  • •Recent neoplasia (< 1 year)
  • •Vitamin B12 deficiency, positive serology for syphilis, thyroid function abnormalities considered to be significant by the care provider.
  • •Use of vitamin or mineral supplements.
  • •Diagnosis of malnutrition (based on body mass index and total protein levels)
  • •Metabolic syndrome or diabetes.
  • •Hormonal replacement therapy.
  • •Chronic inflammatory disease (e.g. rheumatoid arthritis) and any other acute illness.

Outcomes

Primary Outcomes

Malondialdehyde assay

Time Frame: At the time of recruitment

Isolated and purified red blood cell membranes will be in vitro exposed to oxidative stress by UV-B radiation. The extent of cell membrane damage will be quantified by the fluorometric determination of malondialdehyde.

Secondary Outcomes

  • Relationship between urinary excretion of cortisol and levels of malondialdehyde(At the time of recruitment)

Investigators

Sponsor
Raffaele Antonelli Incalzi
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Raffaele Antonelli Incalzi

Professor

Campus Bio-Medico University

Study Sites (1)

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