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Isolated Erythrocyte Membrane Susceptibility to Photo-oxidative Stress in Alzheimer's Disease

This study is not yet open for participant recruitment.
Verified October 2012 by Campus Bio-Medico University
Sponsor:
Information provided by (Responsible Party):
Raffaele Antonelli Incalzi, Campus Bio-Medico University
ClinicalTrials.gov Identifier:
NCT01707719
First received: October 1, 2012
Last updated: October 15, 2012
Last verified: October 2012
History of Changes
  Purpose

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

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.

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

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


Condition
Alzheimer Disease
Oxidative Stress
Adrenocortical Hyperfunction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Isolated Erythrocyte Membrane Susceptibility to Photo-oxidative Stress in Patients Affected by Alzheimer's Disease and Healthy Controls

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Campus Bio-Medico University:

Primary Outcome Measures:
  • Malondialdehyde assay [ Time Frame: At the time of recruitment ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Relationship between urinary excretion of cortisol and levels of malondialdehyde [ Time Frame: At the time of recruitment ] [ Designated as safety issue: No ]
    Hyperactivity of the hypothalamic pituitary adrenal axis has been frequently described in Alzheimer's disease. Recently published work reported an association between high secretion of cortisol and oxidative stress. We will investigate the relationship between 24 h excretion of urinary cortisol and the level of malondialdehyde, produced by isolated and purified red blood cell membranes, in vitro exposed to oxidative stress by UV-B radiation.


Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Alzheimer's disease
Non demented subjects

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients meeting NINCDS-ADRDA criteria for Alzheimer's disease and age- / sex-matched elderly subjects without dementia, will be recruited from those referring neurologists or geriatricians on an outpatient basis

Criteria

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.
  • Smoking
  • Chronic inflammatory disease (e.g. rheumatoid arthritis) and any other acute illness.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707719

Contacts
Contact: Raffaele Antonelli Incalzi, M.D. +39-06-225411 r.antonelli@unicampus.it

Locations
Italy
Policlinico Universitario Campus Bio-Medico Not yet recruiting
Rome, RM, Italy, 00128
Contact: Raffaele Antonelli Incalzi, M.D.     +39-06-225411     r.antonelli@unicampus.it    
Contact: Francesco Maria Serino, M.D.     +39-06-225411 ext 9123     f.serino@unicampus.it    
Sponsors and Collaborators
Raffaele Antonelli Incalzi
Investigators
Principal Investigator: Francesco Maria Serino, M.D. University Campus Bio-Medico
Principal Investigator: Chiara Fanali, PhD University Campus Bio-Medico
Principal Investigator: Laura Dugo, PhD University Campus Bio-Medico
Principal Investigator: Simone Grasso, PhD University Campus Bio-Medico
Study Chair: Ettore Bergamini, M.D. University of Pisa
Principal Investigator: Francesca Ursini, M.D. University Campus Bio-Medico
Principal Investigator: Fabrizio Vernieri, M.D. University Campus Bio-Medico
Study Director: Marina Dachà, BS.Pharm University Campus Bio-Medico
  More Information

Publications:

Responsible Party: Raffaele Antonelli Incalzi, Professor, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT01707719     History of Changes
Other Study ID Numbers: ERASE
Study First Received: October 1, 2012
Last Updated: October 15, 2012
Health Authority: Italy: National Institute of Health

Keywords provided by Campus Bio-Medico University:
Alzheimer's disease
Oxidative stress
HPA axis

Additional relevant MeSH terms:
Adrenocortical Hyperfunction
Alzheimer Disease
Disease Susceptibility
Genetic Predisposition to Disease
Adrenal Gland Diseases
Endocrine System Diseases
Dementia
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013