NCT01707719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
2.6 years until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

January 23, 2020

Status Verified

March 1, 2018

Enrollment Period

3.4 years

First QC Date

October 1, 2012

Last Update Submit

January 22, 2020

Conditions

Alzheimer DiseaseOxidative StressAdrenocortical Hyperfunction

Keywords

Alzheimer's diseaseOxidative stressHPA axis

Outcome Measures

Primary Outcomes (1)

  • Malondialdehyde assay

    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.

    At the time of recruitment

Secondary Outcomes (1)

  • Relationship between urinary excretion of cortisol and levels of malondialdehyde

    At the time of recruitment

Study Arms (2)

Alzheimer's disease

Non demented subjects

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Universitario Campus Bio-Medico

Rome, RM, 00128, Italy

Location

Related Publications (17)

  • Mangialasche F, Polidori MC, Monastero R, Ercolani S, Camarda C, Cecchetti R, Mecocci P. Biomarkers of oxidative and nitrosative damage in Alzheimer's disease and mild cognitive impairment. Ageing Res Rev. 2009 Oct;8(4):285-305. doi: 10.1016/j.arr.2009.04.002. Epub 2009 Apr 17.

    PMID: 19376275BACKGROUND

  • Markesbery WR. Oxidative stress hypothesis in Alzheimer's disease. Free Radic Biol Med. 1997;23(1):134-47. doi: 10.1016/s0891-5849(96)00629-6.

    PMID: 9165306BACKGROUND

  • Perry G, Nunomura A, Hirai K, Zhu X, Perez M, Avila J, Castellani RJ, Atwood CS, Aliev G, Sayre LM, Takeda A, Smith MA. Is oxidative damage the fundamental pathogenic mechanism of Alzheimer's and other neurodegenerative diseases? Free Radic Biol Med. 2002 Dec 1;33(11):1475-9. doi: 10.1016/s0891-5849(02)01113-9.

    PMID: 12446204BACKGROUND

  • Mecocci P. Oxidative stress in mild cognitive impairment and Alzheimer disease: a continuum. J Alzheimers Dis. 2004 Apr;6(2):159-63. doi: 10.3233/jad-2004-6207.

    PMID: 15096699BACKGROUND

  • Polidori MC, Mecocci P. Plasma susceptibility to free radical-induced antioxidant consumption and lipid peroxidation is increased in very old subjects with Alzheimer disease. J Alzheimers Dis. 2002 Dec;4(6):517-22. doi: 10.3233/jad-2002-4608.

    PMID: 12629261BACKGROUND

  • Galbusera C, Facheris M, Magni F, Galimberti G, Sala G, Tremolada L, Isella V, Guerini FR, Appollonio I, Galli-Kienle M, Ferrarese C. Increased susceptibility to plasma lipid peroxidation in Alzheimer disease patients. Curr Alzheimer Res. 2004 May;1(2):103-9. doi: 10.2174/1567205043332171.

    PMID: 15975074BACKGROUND

  • Casado A, Encarnacion Lopez-Fernandez M, Concepcion Casado M, de La Torre R. Lipid peroxidation and antioxidant enzyme activities in vascular and Alzheimer dementias. Neurochem Res. 2008 Mar;33(3):450-8. doi: 10.1007/s11064-007-9453-3. Epub 2007 Aug 25.

    PMID: 17721818BACKGROUND

  • Serra JA, Dominguez RO, de Lustig ES, Guareschi EM, Famulari AL, Bartolome EL, Marschoff ER. Parkinson's disease is associated with oxidative stress: comparison of peripheral antioxidant profiles in living Parkinson's, Alzheimer's and vascular dementia patients. J Neural Transm (Vienna). 2001;108(10):1135-48. doi: 10.1007/s007020170003.

    PMID: 11725816BACKGROUND

  • Kawamoto EM, Munhoz CD, Glezer I, Bahia VS, Caramelli P, Nitrini R, Gorjao R, Curi R, Scavone C, Marcourakis T. Oxidative state in platelets and erythrocytes in aging and Alzheimer's disease. Neurobiol Aging. 2005 Jun;26(6):857-64. doi: 10.1016/j.neurobiolaging.2004.08.011.

    PMID: 15718044BACKGROUND

  • Bermejo P, Gomez-Serranillos P, Santos J, Pastor E, Gil P, Martin-Aragon S. Determination of malonaldehyde in Alzheimer's disease: a comparative study of high-performance liquid chromatography and thiobarbituric acid test. Gerontology. 1997;43(4):218-22. doi: 10.1159/000213853.

    PMID: 9222750BACKGROUND

  • Baldeiras I, Santana I, Proenca MT, Garrucho MH, Pascoal R, Rodrigues A, Duro D, Oliveira CR. Peripheral oxidative damage in mild cognitive impairment and mild Alzheimer's disease. J Alzheimers Dis. 2008 Sep;15(1):117-28. doi: 10.3233/jad-2008-15110.

    PMID: 18780972BACKGROUND

  • Torres LL, Quaglio NB, de Souza GT, Garcia RT, Dati LM, Moreira WL, Loureiro AP, de Souza-Talarico JN, Smid J, Porto CS, Bottino CM, Nitrini R, Barros SB, Camarini R, Marcourakis T. Peripheral oxidative stress biomarkers in mild cognitive impairment and Alzheimer's disease. J Alzheimers Dis. 2011;26(1):59-68. doi: 10.3233/JAD-2011-110284.

    PMID: 21593563BACKGROUND

  • Onaran I, Yalcin AS, Sultuybek G. Effect of donor age on the susceptibility of erythrocytes and erythrocyte membranes to cumene hydroperoxide-induced oxidative stress. Mech Ageing Dev. 1997 Nov;98(2):127-38. doi: 10.1016/s0047-6374(97)00078-x.

    PMID: 9379709BACKGROUND

  • Garcia-Arumi E, Andreu AL, Lopez-Hellin J, Schwartz S. Effect of oxidative stress on lymphocytes from elderly subjects. Clin Sci (Lond). 1998 Apr;94(4):447-52. doi: 10.1042/cs0940447.

    PMID: 9640351BACKGROUND

  • Davis KL, Davis BM, Greenwald BS, Mohs RC, Mathe AA, Johns CA, Horvath TB. Cortisol and Alzheimer's disease, I: Basal studies. Am J Psychiatry. 1986 Mar;143(3):300-5. doi: 10.1176/ajp.143.3.300.

    PMID: 3953862BACKGROUND

  • Costantini D, Marasco V, Moller AP. A meta-analysis of glucocorticoids as modulators of oxidative stress in vertebrates. J Comp Physiol B. 2011 May;181(4):447-56. doi: 10.1007/s00360-011-0566-2. Epub 2011 Mar 18.

    PMID: 21416253BACKGROUND

  • Joergensen A, Broedbaek K, Weimann A, Semba RD, Ferrucci L, Joergensen MB, Poulsen HE. Association between urinary excretion of cortisol and markers of oxidatively damaged DNA and RNA in humans. PLoS One. 2011;6(6):e20795. doi: 10.1371/journal.pone.0020795. Epub 2011 Jun 7.

    PMID: 21687734BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Alzheimer DiseaseAdrenocortical Hyperfunction

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersAdrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • Francesco Maria Serino, M.D. PhD

    Doctors in Italy

    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

    PRINCIPAL INVESTIGATOR

  • Ettore Bergamini, M.D.

    University of Pisa

    STUDY CHAIR

  • Francesca Ursini, M.D.

    University Campus Bio-Medico

    PRINCIPAL INVESTIGATOR

  • Fabrizio Vernieri, M.D.

    University Campus Bio-Medico

    PRINCIPAL INVESTIGATOR

  • Marina Dachà, BS.Pharm

    University Campus Bio-Medico

    STUDY DIRECTOR

  • Silvia Bernardini, M.D.

    University Campus Bio-Medico

    PRINCIPAL INVESTIGATOR

  • Valentina Pasqualetti, PhD

    University Campus Bio-Medico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 1, 2012

First Posted

October 16, 2012

Study Start

June 1, 2015

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

January 23, 2020

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)