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Locus Coeruleus Function Assessment for Alzheimer's Disease Risk (LEAD Trial)
N/A
Waitlist Available
Led By Ricardo Osorio
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 4 (1-4 weeks after lp)
Awards & highlights
LEAD Trial Summary
This trial aims to test whether abnormalities in the locus coeruleus, a brainstem region, can be measured in people with preclinical Alzheimer's disease and whether these abnormalities affect sleep and attention.
Who is the study for?
This trial is for cognitively normal adults aged 60-75 with at least 12 years of education. Participants must have no significant neurological or psychiatric issues, a reliable informant to confirm their interview, and score well on dementia and cognitive tests. Excluded are those with substance abuse history, certain medical conditions or devices that interfere with MRI, irregular sleep patterns, medications affecting cognition/sleep, or a family history of early-onset dementia.Check my eligibility
What is being tested?
The study investigates if locus coeruleus (LC) dysfunction in older adults can be linked to early Alzheimer's disease stages by affecting sleep and attention. It involves overnight sleep monitoring (NPSG), spinal fluid analysis (LP), brain imaging using [11C]MRB PET-MR to target LC function, and attention performance testing (PVT).See study design
What are the potential side effects?
Potential side effects may include discomfort from the lumbar puncture procedure such as back pain or headache; risks associated with PET-MR like allergic reactions to tracers; temporary fatigue after tests; and possible anxiety related to undergoing various assessments.
LEAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 4 (1-4 weeks after lp)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 4 (1-4 weeks after lp)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Oddball Test Response Time
Mean Psychomotor Vigilance Test (PVT) Reaction Time
Methylreboxetine (MRB)-LC Mean Standardized Uptake Value Ratio (SUVR) Values
+5 moreSecondary outcome measures
Levels of Hyperphosphorylated Tau (P-Tau, T-Tau)
Other outcome measures
Aβ42/Aβ40 Ratio
LEAD Trial Design
1Treatment groups
Experimental Treatment
Group I: Cognitively Normal (CN) Older AdultsExperimental Treatment4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psychomotor Vigilance Task (PVT)
2020
N/A
~30
Nocturnal polysomnography (NPSG)
2020
N/A
~30
Lumbar Puncture (LP)
2005
N/A
~850
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,691 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,669 Previous Clinical Trials
28,005,084 Total Patients Enrolled
Ricardo OsorioPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 60 and 75 years old with normal thinking abilities.I have irregular sleep patterns or severe sleep apnea.I am not on medications that affect my thinking or sleep.My family member or partner can confirm my health information.I do not have a history of serious brain conditions or significant brain damage.I use insulin for my diabetes.I have a significant heart, lung, hormone, or blood condition.A close family member had dementia before 60.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitively Normal (CN) Older Adults
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the eligibility criteria for this trial restricted to adults aged 18 and above?
"As stated in the terms of inclusion, those hoping to partake must be between 60 and 75 years old."
Answered by AI
Are there any vacant spots remaining in this research project?
"Clinicaltrials.gov reveals that this clinical trial is open to applicants; the research was initially announced on August 6th 2020, and has been modified most recently October 19th 2022."
Answered by AI
How many participants are currently being enrolled in this clinical research?
"Affirmative. The publically available details on clinicaltrials.gov display that this research is open to participants, after being initially posted on August 6th 2020 and last amended on October 19th 2022. Currently, 30 volunteers are needed from two different medical facilities."
Answered by AI
Do the requirements for this research trial align with my qualifications?
"To qualify for this research project, applicants must have a diagnosis of Alzheimer's disease and be within the range of 60 to 75 years old. The clinical trial is currently seeking thirty participants."
Answered by AI
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