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AzTrials

Alzheimer's DiseaseLIDEALNCT02303158

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

An observational study of Alzheimer's Disease, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Alzheimer's Disease
How many people
50 participants
Where
1 siteSpain
Study dates
Jan 2014to Oct 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • >= 60 years.
  • GDS (Reisberg Gobal Dementia Scale) of 2 to 3.
  • Geriatric Depression Scale of Yesavage >=12.
  • History of previous depressive episodes resolved, but the emotional situation 15 months before inclusion, necessarily have to be normal.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital de Tortosa, Verge de la Cinta

    Tortosa, Tarragona, 43500

Other trials in Spain

About this study

Official title: Study of the Relationship Between Protein Biomarkers in Cerebrospinal Fluid and the Risk of Progression to Alzheimer&Apos;s Disease in a Cohort of Patients With Depression

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

Groups of subjects: patients with recent apparition of late life depression without fulfilling the dementia criteria (Global Deterioration Scale, GDS, stages 1, 2 and 3). A longitudinal, prospective population study with two years follow-up. A cohort of will be included in the study. The patient's depression will be defined and categorized according to its severity (Yesavage Scale), whether it's endogenous or reactive (Holmes and Rahe scale) and taking into account the patient's medical history of depression.

There will be a prospective follow-up of conversion to dementia (starting from GDS Stage 4). It will be considered that dementia corresponds to AD if the biological markers of LCR present typical changes of AD at the moment of inclusion (Beta amyloid low and P-tau high).

It will be studied if there's any correlation between the clinically defined depression types and a high risk of progression to dementia and especially to AD.

Keywords
Alzheimer's Disease, Biomarkers, Depression, dementia, cerebrospinal fluid, neuropsychological
Medical subject headings
Alzheimer Disease, Depression, Dementia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: between the second and the fifth day after inclusion visit

Secondary outcomes (2)

  1. Conversion to dementia

    Measure increases scores in Global Dementia Scale (GDS), considering no dementia GDS from 1 until 3, and evolution to dementia GDS form 3 until 6

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

  2. Depression subtypes

    classify the type of depression by scores in two scales. One of them is Yesavage with scores between 11-17 corresponding with "low depression" and scores between 18-30 with "major depression". the second ones is Vital Stressors Scale of Holmes and Rahe which define adaptative depression as scores upper than 150 and non adaptative depression as scores between 0 and 150.

    Subtype of depression will be correlated with posterior evolution to dementia at final visit (after 24 months +/- 5 days)

    Measured: at basal visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionFeb 2016
  4. Study completionOct 2018

Why it stopped: futility of the sample

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02303158
Sponsor's protocol ID
IISPV-LIDEAL-HTVC
Acronym
LIDEAL
Status last verified
Oct 2018
First submitted
30 May 2014
Last updated
9 Oct 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24374487

  • 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.

    PubMed 23791538

  • 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.

    PubMed 23637108

  • 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.

    PubMed 23574921

  • 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.

    PubMed 23567400

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

    PubMed 23209065

  • 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.

    PubMed 23395197

  • 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.

    PubMed 22815126

  • 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.

    PubMed 24849862

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer's Disease, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: futility of the sample). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analysis of cerebrospinal fluid (time frame: between the second and the fifth day after inclusion visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02303158, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.

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