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NCT03507257 | RECRUITING | Early Onset Alzheimer Disease

Longitudinal Early-onset Alzheimer's Disease Study Protocol
Sponsor:

Indiana University

Information provided by (Responsible Party):

Liana Apostolova

Brief Summary:

The Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is a non-randomized, natural history, non-treatment study designed to look at disease progression in individuals with early onset cognitive impairment. Clinical, cognitive, imaging, biomarker, and genetic characteristics will be assessed across three cohorts: (1) early onset Alzheimer's Disease (EOAD) participants, (2) early onset non-Alzheimer's Disease (EOnonAD) participants, and (3) cognitively normal (CN) control participants.

Condition or disease

Early Onset Alzheimer Disease

Alzheimer Disease

Mild Cognitive Impairment

Intervention/treatment

Flortaucipir

Florbetaben

Fluorodeoxyglucose

Detailed Description:

The LEADS study is a non-randomized, natural history, non-treatment study. Enrolled participants must be 40 - 64 (inclusive) years of age, with MCI due to AD or probable AD dementia (cognitively impaired participants) or have no significant memory impairment (cognitively normal \[CN\] participants). Approximately 850 participants with cognitive impairment (650 with early onset Alzheimer's Disease \[EOAD\] and 200 with early onset non-Alzheimer's Disease \[EOnonAD\]) and 100 CN participants will be enrolled at approximately 20 sites in the United States. At approximately 5 sites outside of the United States, approximately 400 cognitively impaired participants and 10 CN participants will be enrolled. Cognitively impaired participants will take part in the study for 48+ months; CN participants will take part in the study for 24+ months. Participants will undergo longitudinal clinical and cognitive assessments, computerized cognitive tests, biomarker and genetic tests, PET (FDG, amyloid and tau) and MRI brain scans, and optional cerebrospinal fluid (CSF) collection. Participants will be invited to consider autopsy brain donation The primary objectives of the LEADS study are to: * collect longitudinal assessments and biomarker data in individuals with early onset cognitive impairment (EOAD / EOnonAD) and cognitively normal (CN) controls; * to compare baseline and longitudinal cognitive and functional characteristics, between EOAD and CN, and EOAD and Late Onset Alzheimer's Disease (LOAD) from the Alzheimer's Disease Neuroimaging Initiative (ADNI); and * to study the associations of longitudinal clinical and cognitive assessments with multimodal imaging and biofluid markers that capture different elements of the AD pathophysiological cascade

Study Type : OBSERVATIONAL
Estimated Enrollment : 850 participants
Official Title : Longitudinal Early-onset Alzheimer's Disease Study Protocol
Actual Study Start Date : 2018-04-30
Estimated Primary Completion Date : 2026-05-31
Estimated Study Completion Date : 2026-05-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 64 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria for Cognitively Impaired (EOAD and EOnonAD) Cohorts Only
  • 1. Meets NIA-AA criteria for MCI due to AD or probable AD dementia
  • 2. Have a global CDR score ≤ 1.0
  • 3. Have capacity to provide informed consent (IC) or has a legal authorized representative or guardian who provides IC
  • 4. Age between 40-64 years (inclusive) at the time of consent
  • 5. Must have a study partner (informant) who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, caregiver) who is generally aware of the participants' daily activities and can provide information about the participant's cognitive and functional performance. If the participant does not have a study partner who spends at least 10 face-to-face hours per week, other arrangements for identifying a viable study partner will be granted on a case-by-case basis by the Site PI
  • 6. Willing and able to complete longitudinal study procedures aside from LP which is an optional procedure
  • 7. Not pregnant or lactating. Women must be two years post-menopausal, be surgically sterile, or have a negative pregnancy test prior to each PET scan
  • 8. Fluent in English or Spanish if enrolled in the U.S.
  • 9. Fluent in English, Spanish, Dutch or Swedish for sites outside the U.S., according to site's spoken language(s).
  • Inclusion Criteria for Cognitively Normal (CN) Cohort Only
    • 1. Meets criteria for cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living
    • 2. Have a global CDR score = 0
    • 3. Have capacity to provide informed consent
    • 4. Have a Mini-Mental State Exam score between 26-30 (inclusive). Exceptions may be made for participant with less than 8 years of education at the discretion of the Site PI
    • 5. Age between 40-64 years (inclusive) at the time of consent
    • 6. Must have a study partner (informant) who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, caregiver) who is generally aware of the participants' daily activities and can provide information about the participant's cognitive and functional performance. If the participant does not have a study partner who spends 10 face-to-face hours per week, other arrangements for identifying a viable study partner will be granted on a case-by-case basis by the Site PI
    • 7. Willing and able to complete longitudinal study procedures aside from LP which is an optional procedure
    • 8. Not pregnant or lactating. Women must be two years post-menopausal, be surgically sterile, or have a negative pregnancy test prior to each PET scan
    • 9. Fluent in English or Spanish if enrolled in the U.S.
    • 10. Fluent in English, Spanish, Dutch or Swedish for sites outside the U.S., according to site's spoken language(s).
    Exclusion Criteria for all (EOAD, EOnonAD and CN) cohorts
    • 1. Meets core clinical criteria for non-AD dementia
    • 2. Two or more first degree relatives with a history of early-onset dementia suggestive of autosomal dominant transmission, unless known pathogenic mutations in APP, PSEN1, PSEN2, MAPT, GRN and C9ORF72 have been excluded
    • 3. Known CLIA certified mutation in an ADAD gene (APP, PSEN1, PSEN2), or other autosomal dominant genes associated with other neurodegenerative disorders (MAPT, GRN, C9ORF72)
    • 4. Contraindications to 3T MRI (e.g., claustrophobia, pacemaker, select aneurismal clip, artificial heart valve, select ear implants, select stents incompatible with 3T MRI, metal fragments or foreign objects in the eyes, skin or body, etc.)
    • 5. Lifetime medical history of a brain disorder other than the disorder causing dementia except for headache (exceptions are allowed at the discretion of the Site PI - e.g., seizure disorder thought to be due to EOAD).
    • 6. MRI scan with evidence of infection or focal lesions, cortical strokes, multiple lacunes (single lacune is allowable unless it meets criteria for strategic lacune affecting cognition)
    • 7. Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol (at the discretion of the Site PI)
    • 8. Research radiation exposure will be assessed by the study physician. If the candidate participant has had more than one nuclear medicine study in the prior 12 months for research-related purposes, study inclusion will require approval from the PET Core
    • 9. Investigational agents are prohibited 30 days prior to entry
    • 10. Previous enrollment in a therapeutic trial targeting amyloid or tau.
    • 11. Participation in other clinical studies with neuropsychological measures, with the exception of participants who are co-enrolled in the NACC Uniform Data Set (UDS) protocol (Note: This criterion is intended to reduce repeat measures effects during neuropsychological testing. Exceptions are allowed at the discretion of the Site PI)
    • 12. Lifetime history of schizophrenia spectrum disorders (DSM-5 criteria)
    • 13. Current history (in previous 12 months) of DSM-5 diagnosis of mania, bipolar disorder with or without psychotic features
    • 14. Current history (in previous 6 months) of moderate or severe substance abuse (nicotine or caffeine is allowed)
    • 15. Suicidal behaviors in the past 12 months or active suicidal ideations
    • 16. Residing in a 24-hour care skilled nursing facility (at the time of screening)
    • 17. (For optional lumbar puncture procedure only)
      • a. Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be not clinically significant by the Site PI i. Platelet count \<100,000/ml ii. INR\>1.2 iii. Abnormal PT or PTT at screening b. Contraindications to the procedure, including but not limited to severe degenerative joint disease, deformity of the spine, history of a bleeding disorder c. Suspected elevated intracranial pressure, Arnold Chiari malformation or mass lesion d. Use of the anticoagulant medications such as but not limited to warfarin, rivaroxaban, dabigatran
      • 18. Deemed ineligible by the Site PI for any other reason
Longitudinal Early-onset Alzheimer's Disease Study Protocol

Location Details

NCT03507257

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Banner Sun Health Research Institute

Sun City, Arizona, United States, 85351

RECRUITING

United States, California

University of California, Los Angeles

Los Angeles, California, United States, 90095

RECRUITING

United States, California

Stanford University

Palo Alto, California, United States, 94304

RECRUITING

United States, California

University of California, San Francisco

San Francisco, California, United States, 94121

RECRUITING

United States, District of Columbia

Georgetown University

Washington, District of Columbia, United States, 20057

RECRUITING

United States, Florida

Mayo Clinic, Jacksonville

Jacksonville, Florida, United States, 32224

RECRUITING

United States, Florida

Vienna Center

Miami Beach, Florida, United States, 33140

RECRUITING

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

RECRUITING

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

RECRUITING

United States, Indiana

Indiana University

Indianapolis, Indiana, United States, 47405

RECRUITING

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21218

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Minnesota

Mayo Clinic, Rochester

Rochester, Minnesota, United States, 55905

RECRUITING

United States, Missouri

Washington University, St. Louis

Saint Louis, Missouri, United States, 63130

RECRUITING

United States, New York

Columbia University

New York, New York, United States, 10032

RECRUITING

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

United States, Rhode Island

Butler Hospital

Providence, Rhode Island, United States, 02906

RECRUITING

United States, Texas

Houston Methodist Hospital

Houston, Texas, United States, 77030

NOT YET RECRUITING

Argentina,

sleep

Buenos Aires, Argentina, C1428 fuck

NOT YET RECRUITING

Netherlands,

Amsterdam UMC

Amsterdam, Netherlands, 1081 HZ

NOT YET RECRUITING

Spain,

Hospital of the Holy Cross and Sant Pau

Barcelona, Spain, 8041

NOT YET RECRUITING

Sweden,

Lund University

Malmö, Sweden, 214 28

NOT YET RECRUITING

United Kingdom,

University College London

London, United Kingdom, WC1N 3BG