Relationship Between Protein Biomarkers in Cerebrospinal Fluid and Alzheimer&Apos;s Disease in Patients With Depression

NCT02303158 | Terminated DMC

• 1 other identifier: IISPV-LIDEAL-HTVC
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

It is currently accepted that depression during midlife is a risk factor for Alzheimer's disease (AD). Furthermore, several prospective population studies have demonstrated that depression is an independent risk factor for incident dementia of different types (e.g. vascular, mixed, Alzheimer's disease). However, it is not clear, what are the mechanisms that link depression and dementia, and if depression can be a prodromal manifestation of AD. There are also studies that suggest that depression could be an initial sign of AD. Objective:

1. 1.Demonstrate that late life depression (over 60 years of age) constitutes the first manifestation of AD.
2. 2.Define by rating scales and life stressors have differential risk profiles evolutionary AD.
3. 3.To study the relationship between the subtypes of depression and CSF biomarkers, neurophycological test and evolution to AD.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; Biomarkers; Depression; dementia; cerebrospinal fluid; neuropsychological

Outcome Measures

Primary Outcomes (1)

• Analysis of cerebrospinal fluid

  Measure alterations in amyloid AB 1-42, total tau protein and phosphorylated tau protein, in pg/ml. Those alterations will be correlated with the evolution to dementia at final visit (after 24 months +/- 5 days)

  between the second and the fifth day after inclusion visit

Secondary Outcomes (2)

• Conversion to dementia

  first measure at inclusion visit and second measure at final visit (after 24 months +- 5 days).

• Depression subtypes

  at basal visit

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Consecutive patients referred from Primary Care and Psychiatry, Neurology with consultations for specialist for cognitive impairment and / or depression who met the inclusion criteria of the study assessment.

You may qualify if:

• \>= 60 years.
• GDS (Reisberg Gobal Dementia Scale) of 2 to 3.
• Geriatric Depression Scale of Yesavage \>=12.

You may not qualify if:

• Established dementia of any cause, or secondary degenerative dementia of any origin
• Primary diagnosis of cognitive impairment with psychiatric illness (schizophrenia , bipolar disorder, personality disorders ... )
• Dual diagnosis of chronic depression, dysthymia more than 15 months duration, or major depression with psychotic or atypical symptoms
• Neuroimaging with significant chronic vascular involvement
• To take drugs with known side effects on cognition and it is suspected that the neuropsychological deficits.
• Moderate or severe sensory deprivation or functional illiteracy in the neuropsychological study can not be performed
• Neoplastic diseasesContraindication to performing a lumbar puncture

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead

Study Sites (1)

Hospital de Tortosa, Verge de la Cinta

Tortosa, Tarragona, 43500, Spain

Location

Related Publications (9)

• Tam CW, Lam LC. Association between late-onset depression and incident dementia in Chinese older persons. East Asian Arch Psychiatry. 2013 Dec;23(4):154-9.

  PMID: 24374487 RESULT

• Gracia-Garcia P, de-la-Camara C, Santabarbara J, Lopez-Anton R, Quintanilla MA, Ventura T, Marcos G, Campayo A, Saz P, Lyketsos C, Lobo A. Depression and incident Alzheimer disease: the impact of disease severity. Am J Geriatr Psychiatry. 2015 Feb;23(2):119-29. doi: 10.1016/j.jagp.2013.02.011. Epub 2013 Jun 20.

  PMID: 23791538 RESULT

• Diniz BS, Butters MA, Albert SM, Dew MA, Reynolds CF 3rd. Late-life depression and risk of vascular dementia and Alzheimer's disease: systematic review and meta-analysis of community-based cohort studies. Br J Psychiatry. 2013 May;202(5):329-35. doi: 10.1192/bjp.bp.112.118307.

  PMID: 23637108 RESULT

• Wallin K, Bostrom G, Kivipelto M, Gustafson Y. Risk factors for incident dementia in the very old. Int Psychogeriatr. 2013 Jul;25(7):1135-43. doi: 10.1017/S1041610213000409. Epub 2013 Apr 11.

  PMID: 23574921 RESULT

• Rosenberg PB, Mielke MM, Appleby BS, Oh ES, Geda YE, Lyketsos CG. The association of neuropsychiatric symptoms in MCI with incident dementia and Alzheimer disease. Am J Geriatr Psychiatry. 2013 Jul;21(7):685-95. doi: 10.1016/j.jagp.2013.01.006. Epub 2013 Feb 6.

  PMID: 23567400 RESULT

• Nozaki S, Yoshimura K, Mimura M. [Depression and dementia: perspectives from clinical studies]. Brain Nerve. 2012 Dec;64(12):1387-97. Japanese.

  PMID: 23209065 RESULT

• Potter GG, Wagner HR, Burke JR, Plassman BL, Welsh-Bohmer KA, Steffens DC. Neuropsychological predictors of dementia in late-life major depressive disorder. Am J Geriatr Psychiatry. 2013 Mar;21(3):297-306. doi: 10.1016/j.jagp.2012.12.009.

  PMID: 23395197 RESULT

• Gao Y, Huang C, Zhao K, Ma L, Qiu X, Zhang L, Xiu Y, Chen L, Lu W, Huang C, Tang Y, Xiao Q. Depression as a risk factor for dementia and mild cognitive impairment: a meta-analysis of longitudinal studies. Int J Geriatr Psychiatry. 2013 May;28(5):441-9. doi: 10.1002/gps.3845. Epub 2012 Jul 19.

  PMID: 22815126 RESULT

• Dubois B, Feldman HH, Jacova C, Hampel H, Molinuevo JL, Blennow K, DeKosky ST, Gauthier S, Selkoe D, Bateman R, Cappa S, Crutch S, Engelborghs S, Frisoni GB, Fox NC, Galasko D, Habert MO, Jicha GA, Nordberg A, Pasquier F, Rabinovici G, Robert P, Rowe C, Salloway S, Sarazin M, Epelbaum S, de Souza LC, Vellas B, Visser PJ, Schneider L, Stern Y, Scheltens P, Cummings JL. Advancing research diagnostic criteria for Alzheimer's disease: the IWG-2 criteria. Lancet Neurol. 2014 Jun;13(6):614-29. doi: 10.1016/S1474-4422(14)70090-0.

  PMID: 24849862 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

cerebrospinal fluid (CSF), blood serum, blood plasma and whole blood

MeSH Terms

Conditions

Alzheimer Disease; Depression; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: November 27, 2014
• Study Start: January 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: October 1, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

ES (1)