Longitudinal Early-onset Alzheimer's Disease Study Protocol
NCT ID: NCT03507257
Last Updated: 2025-07-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
850 participants
Study Classification
OBSERVATIONAL
Study Start Date
2018-04-30
Study Completion Date
2026-05-31
Brief Summary
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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.
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Detailed Description
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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
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
Conditions
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Early Onset Alzheimer Disease
Alzheimer Disease
Mild Cognitive Impairment
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Early Onset Alzheimer's Disease (EOAD)
* Diagnosis of NIA-AA criteria of MCI due to AD or probable AD dementia
* Amyloid positive status (florbetaben PET scan with evidence of elevated amyloid as determined by a central read)
* CDR score ≤ 1.0
* flortaucipir (18F-AV-1451) PET scanning
Flortaucipir
Intervention Type
DRUG
All participants will receive a single bolus intravenous injection of approximately 10 mCi (+/- 10%, 20μg mass dose) of flortaucipir (18F-AV-1451). At approximately 75-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
Florbetaben
Intervention Type
DRUG
All participants will receive a single bolus intravenous injection of approximately 8 mCi +/- .8mCi of florbetaben (AV-45). At approximately 90-minutes (+/- 10 minutes) post dose, scanning will begin. An approximately 20-minute image acquisition scan will be performed.
Cognitively Normal (CN) Controls
* Meets criteria for cognitively normal, based on an absence of significant impairment in cognitive functions and activities of daily living
* Mini-Mental State Exam score between 26-30
* CDR score = 0
* flortaucipir (18F-AV-1451) PET scanning
Flortaucipir
Intervention Type
DRUG
All participants will receive a single bolus intravenous injection of approximately 10 mCi (+/- 10%, 20μg mass dose) of flortaucipir (18F-AV-1451). At approximately 75-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
Florbetaben
Intervention Type
DRUG
All participants will receive a single bolus intravenous injection of approximately 8 mCi +/- .8mCi of florbetaben (AV-45). At approximately 90-minutes (+/- 10 minutes) post dose, scanning will begin. An approximately 20-minute image acquisition scan will be performed.
Fluorodeoxyglucose
Intervention Type
DRUG
All participants will receive a single bolus intravenous injection of approximately 5 mCi (+/- 10%, 0.5 mCi) of fluorodeoxyglucose. At approximately 30 minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
Early Onset non-Alzheimer's Disease (EOnonAD)
* Diagnosis of NIA-AA criteria of MCI due to AD or probable AD dementia
* Amyloid negative status (florbetaben PET scan with no evidence of elevated amyloid as determined by a central read)
* CDR score ≤ 1.0
* flortaucipir (18F-AV-1451) PET scanning
Flortaucipir
Intervention Type
DRUG
All participants will receive a single bolus intravenous injection of approximately 10 mCi (+/- 10%, 20μg mass dose) of flortaucipir (18F-AV-1451). At approximately 75-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
Florbetaben
Intervention Type
DRUG
All participants will receive a single bolus intravenous injection of approximately 8 mCi +/- .8mCi of florbetaben (AV-45). At approximately 90-minutes (+/- 10 minutes) post dose, scanning will begin. An approximately 20-minute image acquisition scan will be performed.
Fluorodeoxyglucose
Intervention Type
DRUG
All participants will receive a single bolus intravenous injection of approximately 5 mCi (+/- 10%, 0.5 mCi) of fluorodeoxyglucose. At approximately 30 minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
Interventions
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Flortaucipir
All participants will receive a single bolus intravenous injection of approximately 10 mCi (+/- 10%, 20μg mass dose) of flortaucipir (18F-AV-1451). At approximately 75-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
Intervention Type
DRUG
Florbetaben
All participants will receive a single bolus intravenous injection of approximately 8 mCi +/- .8mCi of florbetaben (AV-45). At approximately 90-minutes (+/- 10 minutes) post dose, scanning will begin. An approximately 20-minute image acquisition scan will be performed.
Intervention Type
DRUG
Fluorodeoxyglucose
All participants will receive a single bolus intravenous injection of approximately 5 mCi (+/- 10%, 0.5 mCi) of fluorodeoxyglucose. At approximately 30 minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
Intervention Type
DRUG
Other Intervention Names
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18F-AV-1451 (also known as [F-18]T807 or LY3191748)
AV-45, Neuraceq
FDG
Eligibility Criteria
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Inclusion Criteria
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).
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).
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).
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
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
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
Minimum Eligible Age
40 Years
Maximum Eligible Age
64 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Alzheimer's Therapeutic Research Institute
OTHER
Sponsor Role
collaborator
National Institute on Aging (NIA)
NIH
Sponsor Role
collaborator
Alzheimer's Association
OTHER
Sponsor Role
collaborator
Indiana University
OTHER
Sponsor Role
lead
Responsible Party
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Liana Apostolova
Professor in Neurology, Radiology, Medical and Molecular Genetics
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Liana Apostolova, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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Banner Sun Health Research Institute
Sun City, Arizona, United States
Site Status
RECRUITING
University of California, Los Angeles
Los Angeles, California, United States
Site Status
RECRUITING
Stanford University
Palo Alto, California, United States
Site Status
RECRUITING
University of California, San Francisco
San Francisco, California, United States
Site Status
RECRUITING
Georgetown University
Washington D.C., District of Columbia, United States
Site Status
RECRUITING
Mayo Clinic, Jacksonville
Jacksonville, Florida, United States
Site Status
RECRUITING
Wien Center
Miami Beach, Florida, United States
Site Status
RECRUITING
Emory University
Atlanta, Georgia, United States
Site Status
RECRUITING
Northwestern University
Chicago, Illinois, United States
Site Status
RECRUITING
Indiana University
Indianapolis, Indiana, United States
Site Status
RECRUITING
Johns Hopkins University
Baltimore, Maryland, United States
Site Status
RECRUITING
Massachusetts General Hospital
Boston, Massachusetts, United States
Site Status
RECRUITING
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Site Status
RECRUITING
Washington University, St. Louis
St Louis, Missouri, United States
Site Status
RECRUITING
Columbia University
New York, New York, United States
Site Status
RECRUITING
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Site Status
RECRUITING
Butler Hospital
Providence, Rhode Island, United States
Site Status
RECRUITING
Houston Methodist Hospital
Houston, Texas, United States
Site Status
RECRUITING
Fleni
Buenos Aires, , Argentina
Site Status
NOT_YET_RECRUITING
Amsterdam UMC
Amsterdam, , Netherlands
Site Status
NOT_YET_RECRUITING
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Site Status
NOT_YET_RECRUITING
Lund University
Malmo, , Sweden
Site Status
NOT_YET_RECRUITING
University College London
London, , United Kingdom
Site Status
NOT_YET_RECRUITING
Countries
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United States
Argentina
Netherlands
Spain
Sweden
United Kingdom
Central Contacts
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Facility Contacts
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References
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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ATRI-003
Identifier Type: -
Identifier Source: org_study_id
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