Longitudinal Evaluation of Amyloid Risk and Neurodegeneration (LEARN) Study

Active Trial/Not Recruiting

Purpose 

The purpose of the LEARN study is to help researchers understand the changes in thinking and memory that may occur in older individuals. The LEARN study is a longitudinal study designed to compare the natural course of aging in individuals with normal cognition who do not have elevated amyloid levels in the brain, to individuals with normal cognition and elevated amyloid brain levels who are enrolled in the A4 Trial. This will be achieved through collection of cognitive, clinical, and biomarker measures (imaging, blood, CSF). Other goals of this study include 1) exploring which cognitive and clinical characteristics predict changes in non-elevated amyloid individuals, 2) evaluating longitudinal changes in amyloid accumulation and neurodegeneration in non-elevated amyloid individuals, and 3) to explore the psychological impact of disclosure of amyloid status to participants, by using questionnaires which probe perception of amyloid imaging and concern about developing Alzheimer's disease. This study will be consist of 11 visits over 4.5 years. To learn more, please call Celine Ossinalde at (310) 794-6191 or send an email to: This email address is being protected from spambots. You need JavaScript enabled to view it.. (PI: Maryam Beigi, MD, Easton Center's Katherine and Benjamin Kagan Alzheimer's Disease Treatment Dev. Program)

Sponsor:  University of Southern California
ClinicalTrials.gov Identifier: NCT02488720

 

Condition: Cognitive Disorders

 

Study Type: Observational
Official Title: 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
Eligibility
Ages Eligible for Study: 65 Years to 85 Years (Older Adult)
Genders Eligible for Study: All
Accepts Healthy Volunteers: Yes
Sampling Method: Probability Sample
Criteria

Source: ClinicalTrials.gov

Inclusion Criteria:

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).
Has a florbetapir PET scan that falls below the Aβ threshold levels required for randomization into the treatment arms of the A4 trial.
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.
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.
In the investigator's opinion, is both willing and able to participate in all required procedures for the duration of the study (at least 240 weeks), including adequate literacy in English or Spanish and adequate vision and hearing to complete the required psychometric tests.

Exclusion Criteria:

Is receiving a prescription acetylcholinesterase inhibitor (AChEI) and/or memantine at LEARN Visit 1.
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.
Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI.
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).
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.
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:
Current use of anticoagulants, such as warfarin or dabigatran.)

Contact: Celine Ossinalde at (310) 794-6191 or This email address is being protected from spambots. You need JavaScript enabled to view it. to participate in this study or for more information.

Health Professionals