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:
Raffaele Antonelli Incalzi
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
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| First Received Date ICMJE | October 1, 2012 | ||||||||||||||||||||||||||||||||
| Last Updated Date | October 15, 2012 | ||||||||||||||||||||||||||||||||
| Start Date ICMJE | October 2012 | ||||||||||||||||||||||||||||||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT01707719 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||||||||||
| Brief Title ICMJE | Isolated Erythrocyte Membrane Susceptibility to Photo-oxidative Stress in Alzheimer's Disease | ||||||||||||||||||||||||||||||||
| Official Title ICMJE | Isolated Erythrocyte Membrane Susceptibility to Photo-oxidative Stress in Patients Affected by Alzheimer's Disease and Healthy Controls | ||||||||||||||||||||||||||||||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||||||||||||||||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||||||||||||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||||||||||||||||||||||||||
| Biospecimen | Retention: Samples With DNA Description: Whole blood |
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| 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 |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||||||||||||||||||||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||||||||||||||||||||||||||
| Estimated Completion Date | October 2013 | ||||||||||||||||||||||||||||||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||||||||||||||
| Ages | 50 Years and older | ||||||||||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Italy | ||||||||||||||||||||||||||||||||
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| NCT Number ICMJE | NCT01707719 | ||||||||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | ERASE | ||||||||||||||||||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||||||||||||||||||
| Responsible Party | Raffaele Antonelli Incalzi, Campus Bio-Medico University | ||||||||||||||||||||||||||||||||
| Study Sponsor ICMJE | Raffaele Antonelli Incalzi | ||||||||||||||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Campus Bio-Medico University | ||||||||||||||||||||||||||||||||
| Verification Date | October 2012 | ||||||||||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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