Longitudinal Evaluation of Amyloid Risk and Neurodegeneration - the LEARN Study



Status:Active, not recruiting
Conditions:Cognitive Studies, Hematology
Therapuetic Areas:Hematology, Psychiatry / Psychology
Healthy:No
Age Range:65 - 85
Updated:10/13/2018
Start Date:September 8, 2015
End Date:June 2020

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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.


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.
We found this trial at
42
sites
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
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Los Angeles, California 90095
310-825-4321
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Los Angeles, California 90033
213) 740-2311
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
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Amherst, New York 14226
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Ann Arbor, Michigan 48105
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Beachwood, Ohio 44122
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One Silber Way
Boston, Massachusetts 02215
(617) 353-2000
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Charleston, South Carolina 29401
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303 East Superior Street
Chicago, Illinois 60611
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
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Fairway, Kansas 66205
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Irvine, California 92697
949-824-5011
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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Jacksonville, Florida 32216
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Lexington, Kentucky
859) 257-9000
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Madison, Wisconsin 53792
(608) 263-2400
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Miami Beach, Florida 33140
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
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100 West Gore Street
Orlando, Florida 32806
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3801 Miranda Avenue
Palo Alto, California 94304
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Phoenix, Arizona 85006
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Providence, Rhode Island 02906
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Sun City, Arizona 85351
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3201 Wedgewood Lane
The Villages, Florida 32162
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Tulsa, Oklahoma 74104
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Washington, District of Columbia 20060
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
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