Characterizing Cognitive Decline in Late Life Depression: The ADNI Depression Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Major Depression, Late Life Depression (LLD). Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Characterizing Cognitive Decline in Late Life Depression: The Alzheimer's Disease Neuroimaging Initiative - Depression Project
Overview
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.
Primary outcome measures
- Rate of Change in neuropsychological measures of executive function as measured by the Digit Symbol Substitution Test using total correct. [Time frame: 5 years (parent protocol), 5 years (continuation)]
- Rate of Change in expressive language as measured by the Boston Naming Test using total correct. [Time frame: 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. [Time frame: 5 years (parent protocol), 5 years (continuation)]
- Change in brain structure using magnetic resonance imaging (MRI) [Time frame: 5 years (parent protocol), 5 years (continuation)]
- Extent of amyloid deposition as measured by florbetapir [Time frame: 5 years (parent protocol), 5 years (continuation)]
- Extent of tau deposition as measured by flortaucipr [Time frame: 5 years (continuation)]
Secondary outcome measures (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). [Time frame: 5 years (parent protocol), 5 years (continuation)]
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:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 2 centers
- University of California, San Francisco — San Francisco
- University of Pittsburgh — Pittsburgh
Publications
- 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
Identifiers
NCT: NCT02434393 · ADC-048 · R01MH098062