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Longitudinal Evaluation of Amyloid Risk and Neurodegeneration - the LEARN Study (LEARN)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Alzheimer's Association
National Institute on Aging (NIA)
Alzheimer's Therapeutic Research Institute
Information provided by (Responsible Party):
Paul Aisen, University of Southern California
ClinicalTrials.gov Identifier:
NCT02488720
First received: June 30, 2015
Last updated: June 30, 2017
Last verified: June 2017
June 30, 2015
June 30, 2017
June 2015
June 2019   (Final data collection date for primary outcome measure)
Change from Baseline of the ADCS Preclinical Alzheimer Cognitive Composite (ADCS-PACC) to Week 168 [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT02488720 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Cognitive Function Index (CFI) to Week 168 [ Time Frame: 3 years ]
  • Change from Baseline in Mean Composite Summary Uptake Value Ratio (SUVr) to Week 168 [ Time Frame: 3 years ]
  • Change from Baseline in Cerebral Spinal Fluid (CSF) Tau Biomarkers to Week 168 [ Time Frame: 3 years ]
  • Change from Baseline of Cerebrospinal Fluid (CSF) Concentrations of Amyloid Beta (Abeta) to Week 168 [ Time Frame: 3 years ]
  • Change from Baseline of Volumetric Magnetic Resonance Imaging (vMRI) to Week 168 [ Time Frame: 3 years ]
Same as current
Not Provided
Not Provided
 
Longitudinal Evaluation of Amyloid Risk and Neurodegeneration - the LEARN Study
Longitudinal Evaluation of Amyloid Risk and Neurodegeneration - the LEARN Study. A Companion Observational Study to Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) Trial

The LEARN study a multicenter, observational study will that will evaluate the rate of cognitive change in approximately 500 clinically normal older individuals who "screen-fail" for the A4 trial on the basis of their screening PET imaging not demonstrating evidence of elevated amyloid accumulation (Aβ negative) but meet all other A4 study eligibility criteria. This study will leverage the A4 infrastructure and maximize the data acquired in screening a large number of well-characterized older adults for the A4 trial.

The LEARN observational cohort will provide a critical comparison group for the A4 placebo arm, and future trials in preclinical AD. Although accumulating longitudinal data suggest that older individuals with elevated Aβ burden are at increased risk of cognitive decline, it is important to demonstrate a differential rate of clinical decline between Aβe ("Aβ elevated") and Aβne ("Aβ not elevated") individuals on a standardized set of clinical outcomes. Over 2000 well-characterized, highly motivated older volunteers will "screen fail" for the A4 trial. The LEARN study will follow 500 of these individuals, matched as closely as possible to the two treatment arms, in this observation cohort. The LEARN study may selectively recruit from a specific range of SUVr that fall below the threshold for "elevated amyloid" in order to support analyses of the relationship of baseline SUVr to subsequent cognitive change and amyloid accumulation. The observational cohort will be followed for 168 weeks with identical clinical/cognitive testing performed every 24 weeks, running parallel to the A4 treatment study.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
blood, CSF
Probability Sample
500 subjects without evidence of elevated ABeta on screening PET scan. Subjects will have consented to participate in the A4 trial and previously met demographic, cognitive and clinical criteria and have an A4 screening PET scan results that fallows below the ABeta threshold levels required for randomization into the treatment arms for the A4 trials.
Cognition Disorders
Not Provided
Clinically normal older inviduals
500 clinically normal older individuals with florbetapir positron emission tomography (PET) scan that does not show evidence of brain amyloid pathology at screening.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
June 2019
June 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Consented to participate in the A4 study and previously met A4 demographic, cognitive and clinical criteria (e.g., Mini-Mental State Examination (MMSE); Clinical Dementia Ratin (CDR); Logical Memory test, part IIa (LMIIa); medications; medical history).
  2. Has a florbetapir PET scan that falls below the Aβ threshold levels required for randomization into the treatment arms of the A4 trial.
  3. In general, permitted medications should be stable for 8 weeks prior to LEARN Visit 1. Changes to medications that, in the opinion of the investigator, are not likely to impact LEARN Visit 1 assessments are permissible.
  4. Has a study partner that is willing to participate as a source of information and has at least weekly contact with the subject (contact can be in-person, via telephone or electronic communication). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the subject's daily function.
  5. In the investigator's opinion, is both willing and able to participate in all required procedures for the duration of the study (at least 168 weeks), including adequate literacy in English or Spanish and adequate vision and hearing to complete the required psychometric tests.

Exclusion Criteria:

  1. Is receiving a prescription acetylcholinesterase inhibitor (AChEI) and/or memantine at LEARN Visit 1
  2. Has current serious or unstable illness including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study.
  3. Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI.
  4. Has a LEARN Visit 1 MRI scan with results showing >4 hemosiderin deposits (definite microhemorrhages or areas of superficial siderosis); or any amyloid-related imaging abnormalities - edema/effusions (ARIA-E).
  5. Has received any exclusionary medication, including those with significant central nervous system (CNS) anticholinergic effects, within 3 months prior to LEARN Visit 1 or initiated at any point after screen. A full list of exclusionary medication will be provided in the relevant procedures manual.
  6. Is currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Participation in observational studies may be permitted upon review of the observational study protocol and approval by the Project Director or one of the ADCS Medical Monitors.

    For subjects participating in the optional Lumbar Puncture (LP, all of the above, plus:

  7. Current use of anticoagulants, such as warfarin or dabigatran.
Sexes Eligible for Study: All
65 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02488720
ADC-051
U19AG010483 ( U.S. NIH Grant/Contract )
15-338729 ( Other Identifier: Alzheimer's Association )
Yes
Not Provided
Not Provided
Paul Aisen, University of Southern California
University of Southern California
  • Alzheimer's Association
  • National Institute on Aging (NIA)
  • Alzheimer's Therapeutic Research Institute
Study Director: Reisa Sperling, MD Center for Alzheimer Research and Treatment Brigham and Women's Hospital
University of Southern California
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP