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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Campus Bio-Medico University.
Recruitment status was  Not yet recruiting
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

October 1, 2012
October 15, 2012
October 2012
April 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01707719 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Isolated Erythrocyte Membrane Susceptibility to Photo-oxidative Stress in Alzheimer's Disease
Isolated Erythrocyte Membrane Susceptibility to Photo-oxidative Stress in Patients Affected by Alzheimer's Disease and Healthy Controls

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Whole blood

Probability Sample

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

  • Alzheimer Disease
  • Oxidative Stress
  • Adrenocortical Hyperfunction
Not Provided
  • Alzheimer's disease
  • Non demented subjects

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
October 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact: Raffaele Antonelli Incalzi, M.D. +39-06-225411 r.antonelli@unicampus.it
Italy
 
NCT01707719
ERASE
Yes
Raffaele Antonelli Incalzi, Campus Bio-Medico University
Raffaele Antonelli Incalzi
Not Provided
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
Campus Bio-Medico University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP