RecruitingEarly Onset Alzheimer DiseaseAlzheimer DiseaseMild Cognitive Impairment

Longitudinal Early-onset Alzheimer's Disease Study Protocol

Eligible age

40–64 yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

Yes

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About this study

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.

Sponsor: Indiana University

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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