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Can a tiny brain region predict Alzheimer's decades early?

NCT ID NCT04403165

Knowledge-focused Sponsor: NYU Langone Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 30 healthy older adults to see if changes in a small brain area called the locus coeruleus could be an early sign of Alzheimer's disease. Researchers used brain scans, sleep tests, and spinal fluid analysis to measure brain function, sleep quality, and attention. The goal was to find new ways to detect Alzheimer's risk long before memory problems start.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Aug 2020

Finished

Mar 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male and female subjects with normal cognition and 55-75 years of age will be enrolled. * Subjects will be within normal limits on neurological and psychiatric examinations. * All subjects enrolled will have a CDR of 0. This will be evaluated through a clinical interview administered by a study physician (informant interview will not be required). * All subjects will have had a minimum of 12 years of education. Exclusion Criteria: * History of brain tumor, MRI evidence of brain damage or brain disease including significant trauma, hydrocephalus, seizures, stroke, mental retardation or other serious neurological disorder (e.g. Parkinson's disease or other movement disorders). * Significant history of alcoholism or drug abuse. * Significant history of psychiatric illness (e.g., schizophrenia, bipolar, PTSD, or life-long history of major depression). * Geriatric Depression Scale (short form)\>6. * Insulin dependent diabetes. * Evidence of clinically relevant cardiac, pulmonary, endocrine or hematological conditions. * Physical impairment of such severity as to adversely affect the validity of psychological testing. * Any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging. * History of a first-degree family member with early onset (age \<60 years) dementia. * Irregular sleep-wake rhythms (based on the actigraphy recordings) or significant OSA (AHI4%≥15). * Taking Coumadin/warfarin and/or medications affecting cognition or sleep. * Failure to complete all study visit within 4 months

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease

Contacts and locations

Locations

  • Icahn School of Medicine Mount Sinai

    New York, New York, 10029, United States

  • NYU Grossman School of Medicine

    New York, New York, 10016, United States

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