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Идёт набор NCT02434393

Characterizing Cognitive Decline in Late Life Depression: The ADNI Depression Project

— Наблюдательное Major Depression Late Life Depression (LLD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Major Depression, Late Life Depression (LLD). Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Characterizing Cognitive Decline in Late Life Depression: The Alzheimer's Disease Neuroimaging Initiative - Depression Project

Обзор

The purpose of this research study is to characterize the mechanisms contributing to cognitive impairment and accelerated cognitive decline in Late Life Depression (LLD). This is a non-randomized, observational, non-treatment study that originally launched in 2015, enrolling 133 participants. From the originally enrolled participants, the continuation of the ADNI-D study will enroll 120 participants which will include following participants from the original (parent) protocol and enrollment of new participants for a period of 30 months. Data from an additional 300 non-depressed subjects will be used from ADNI studies for comparison. Depression history, symptom severity and health information will be collected at the initial visit to determine eligibility. An magnetic resonance imaging (MRI) scan, as well as amyloid (florbetapir) and tau (flortaucipr) positron emission tomography (PET) imaging will be conducted at San Francisco VA. Collection of plasma and serum for biomarkers, clinical assessments and cognitive assessments will be conducted at two time points. Blood samples will also be collected for genetic analysis.

Первичные конечные точки

  • Rate of Change in neuropsychological measures of executive function as measured by the Digit Symbol Substitution Test using total correct. [Срок оценки: 5 years (parent protocol), 5 years (continuation)]
  • Rate of Change in expressive language as measured by the Boston Naming Test using total correct. [Срок оценки: 5 years (parent protocol), 5 years (continuation)]
  • Rate of change in learning and memory as measured by the Rey Auditory Verbal Learning Test using total correct and delayed recall. [Срок оценки: 5 years (parent protocol), 5 years (continuation)]
  • Change in brain structure using magnetic resonance imaging (MRI) [Срок оценки: 5 years (parent protocol), 5 years (continuation)]
  • Extent of amyloid deposition as measured by florbetapir [Срок оценки: 5 years (parent protocol), 5 years (continuation)]
  • Extent of tau deposition as measured by flortaucipr [Срок оценки: 5 years (continuation)]
Вторичные конечные точки (1)
  • Use biomarkers data employed in ADNI-2 and the NIA AD (Alzheimer's Disease) Genetics Consortium to determine the genotypes needed for the genome wide association study (GWAS). [Срок оценки: 5 years (parent protocol), 5 years (continuation)]

Критерии участия

Критерии включения

1\. Individual participated in original Characterizing Cognitive Decline in Late Life Depression study or Multimodal MRI Characteristics of Psychotherapy Response in Late Life Depression Study.

Exclusion Exceptions:

  • Antidepressant medication treatment is allowed only if the medication dose is stable for 4 weeks prior to the MRI scan.
  • Psychotherapy interventions is allowed only if they have completed at least 4 weeks of individual or group psychotherapy intervention prior to the MRI scan.
  • Participants taking cognitive enhancing medications will be able to enter the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 2 центра
  • University of California, San Francisco — San Francisco
  • University of Pittsburgh — Pittsburgh

Публикации

  • Lyness JM, Niculescu A, Tu X, Reynolds CF 3rd, Caine ED. The relationship of medical comorbidity and depression in older, primary care patients. Psychosomatics. 2006 Sep-Oct;47(5):435-9. doi: 10.1176/appi.psy.47.5.435. PMID 16959933
  • McCusker J, Cole M, Ciampi A, Latimer E, Windholz S, Belzile E. Major depression in older medical inpatients predicts poor physical and mental health status over 12 months. Gen Hosp Psychiatry. 2007 Jul-Aug;29(4):340-8. doi: 10.1016/j.genhosppsych.2007.03.007. PMID 17591511
  • Gabryelewicz T, Styczynska M, Luczywek E, Barczak A, Pfeffer A, Androsiuk W, Chodakowska-Zebrowska M, Wasiak B, Peplonska B, Barcikowska M. The rate of conversion of mild cognitive impairment to dementia: predictive role of depression. Int J Geriatr Psychiatry. 2007 Jun;22(6):563-7. doi: 10.1002/gps.1716. PMID 17136705
  • Rapp MA, Gerstorf D, Helmchen H, Smith J. Depression predicts mortality in the young old, but not in the oldest old: results from the Berlin Aging Study. Am J Geriatr Psychiatry. 2008 Oct;16(10):844-52. doi: 10.1097/JGP.0b013e31818254eb. PMID 18827231
  • Ganzini L, Smith DM, Fenn DS, Lee MA. Depression and mortality in medically ill older adults. J Am Geriatr Soc. 1997 Mar;45(3):307-12. doi: 10.1111/j.1532-5415.1997.tb00945.x. PMID 9063276

Идентификаторы

NCT: NCT02434393 · ADC-048 · R01MH098062

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗