Clinical trial NCT02434393: Characterizing Cognitive Decline in Late Life Depression: The ADNI Depression Project
Official title: Characterizing Cognitive Decline in Late Life Depression: The Alzheimer's Disease Neuroimaging Initiative - Depression Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Major Depression
Late Life Depression (LLD)
Keywords: Depression
Late Life Depression
LLD
amyloid imaging
biomarkers
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of California, San Francisco
name: Alzheimer's Therapeutic Research Institute
First posted: 2015-05-05
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 120 older adults meeting criteria for Major Depression or Late Life Depression (LLD).

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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:

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

Primary outcomes:
measure: Rate of Change in neuropsychological measures of executive function as measured by the Digit Symbol Substitution Test using total correct.
timeFrame: 5 years (parent protocol), 5 years (continuation)
measure: Rate of Change in expressive language as measured by the Boston Naming Test using total correct.
timeFrame: 5 years (parent protocol), 5 years (continuation)
measure: Rate of change in learning and memory as measured by the Rey Auditory Verbal Learning Test using total correct and delayed recall.
timeFrame: 5 years (parent protocol), 5 years (continuation)
measure: Change in brain structure using magnetic resonance imaging (MRI)
timeFrame: 5 years (parent protocol), 5 years (continuation)
measure: Extent of amyloid deposition as measured by florbetapir
timeFrame: 5 years (parent protocol), 5 years (continuation)
measure: Extent of tau deposition as measured by flortaucipr
timeFrame: 5 years (continuation)
Secondary outcomes:
measure: 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).
timeFrame: 5 years (parent protocol), 5 years (continuation)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of California, San Francisco
name: Scott Mackin, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.