Tracking early-onset memory loss and brain changes over time

Plain-English translation of NCT03507257 on ClinicalTrials.gov ↗ · Source last updated February 2026 · Translation generated June 2026 · How we translate trials

What is this trial?

The LEADS study is a long-term observational research effort designed to better understand early-onset Alzheimer's disease and other early memory problems in younger adults (ages 40–64). Researchers will track participants over time using brain scans, memory tests, blood work, and genetic testing to see how cognition and brain health change and what biological markers predict these changes. This study does not test a new medication—instead, it gathers detailed information to help scientists learn more about who develops these conditions and how they progress.

Most research on memory loss and Alzheimer's disease has focused on older adults, leaving a significant gap in understanding why some younger people develop these problems and how the disease differs in this age group. This study aims to fill that gap by collecting detailed, long-term data that could eventually lead to better detection, treatment, and prevention strategies for people diagnosed earlier in life.

Do you qualify?

You likely qualify if…

you are between 40 and 64 years old
you have been diagnosed with mild cognitive impairment or probable Alzheimer's disease due to amyloid buildup in the brain, or you have normal cognition with no significant memory problems
you have a study partner (such as a family member, close friend, or caregiver) who sees you at least 10 hours per week and can report on your daily activities and cognitive changes
you are fluent in English or Spanish (in the U.S.) or English, Spanish, Dutch, or Swedish (outside the U.S.)
you are able and willing to complete study procedures including brain scans, memory tests, and optional spinal fluid collection over 24–48 months

You likely don't qualify if…

you have been diagnosed with a non-Alzheimer's dementia (such as frontotemporal or Lewy body dementia) as your primary condition
you have two or more close relatives who developed early-onset dementia
you are pregnant, breastfeeding, or not two years past menopause (if female) unless surgically sterile
you are unable to provide informed consent and do not have a legal authorized representative or guardian

What participation looks like

Participants will visit study sites multiple times over 2–4 years, depending on whether they have memory problems (longer follow-up) or normal cognition (shorter follow-up). At each visit, they will complete memory and thinking tests, brain scans (PET and MRI), blood work, and genetic testing; spinal fluid collection is optional. A study partner will also provide information about the participant's everyday functioning. The study is purely observational—researchers are watching and measuring, not giving any new treatment.

AI-generated summary from trial data · Jun 13, 2026 · Not medical advice

Trial locations(23 sites)

United States

Banner Sun Health Research Institute, Sun City, Arizona

University of California, Los Angeles, Los Angeles, California

Stanford University, Palo Alto, California

University of California, San Francisco, San Francisco, California

Georgetown University, Washington D.C., District of Columbia