PET-MR measurement with a norepinephrine transporter (NET)-selective radiotracer (S,S)-[11C]Omethylreboxetine ([11C]MRB) for Alzheimer's Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NYU Grossman School of Medicine, New York, NYAlzheimer's DiseasePET-MR measurement with a norepinephrine transporter (NET)-selective radiotracer (S,S)-[11C]Omethylreboxetine ([11C]MRB) - Other
Eligibility
60 - 75
All Sexes
What conditions do you have?
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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[11C]-NOP46
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PET/CT Scan with FNP-59
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Radiotracer

Study Objectives

8 Primary · 1 Secondary · Reporting Duration: Visit 4 (1-4 weeks after LP)

Week 4
Mean Oddball Test Response Time
Mean Psychomotor Vigilance Test (PVT) Reaction Time
N2 Spindle Density
Percentage of Correct Responses
Percentage of Time Spent in REM Sleep
REM Sleep Continuity
Total REM Duration (Min)
Week 4
Aβ42/Aβ40 Ratio
Levels of Hyperphosphorylated Tau (P-Tau, T-Tau)
Methylreboxetine (MRB)-LC Mean Standardized Uptake Value Ratio (SUVR) Values

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
[11C]-NOP46
1
PET/CT Scan with FNP-59
1
Radiotracer

Side Effects for

Venlafaxine XR
49%Dry mouth
41%Drowsiness
39%Lightheadedness
36%Headache
34%Increased sweating
33%Nausea
31%Insomnia
29%Nightmares
29%Constipation
28%Jitteriness
28%Fatigue
25%Flatulence
25%Decreased Sex Drive
21%Decreased Orgasm
19%Muscle Aches
13%Diarrhea
10%Abdominal Pain
8%Faintness
7%Delayed Orgasm
7%Gas
This histogram enumerates side effects from a completed 2009 Phase 4 trial (NCT00183274) in the Venlafaxine XR ARM group. Side effects include: Dry mouth with 49%, Drowsiness with 41%, Lightheadedness with 39%, Headache with 36%, Increased sweating with 34%.

Trial Design

1 Treatment Group

Cognitively Normal (CN) Older Adults
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: PET-MR measurement with a norepinephrine transporter (NET)-selective radiotracer (S,S)-[11C]Omethylreboxetine ([11C]MRB) · No Placebo Group · N/A

Cognitively Normal (CN) Older AdultsExperimental Group · 4 Interventions: PET-MR measurement with a norepinephrine transporter (NET)-selective radiotracer (S,S)-[11C]Omethylreboxetine ([11C]MRB), Psychomotor Vigilance Task (PVT), Nocturnal polysomnography (NPSG), Lumbar Puncture (LP) · Intervention Types: Other, Behavioral, Procedure, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumbar Puncture (LP)
2005
N/A
~820

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: visit 4 (1-4 weeks after lp)

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,274 Previous Clinical Trials
757,921 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,442 Previous Clinical Trials
4,246,746 Total Patients Enrolled
Ricardo OsorioPrincipal InvestigatorNYU Langone Health

Eligibility Criteria

Age 60 - 75 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You need to have a normal neurological and mental health evaluation.
You do not have dementia and your cognitive abilities are within a certain range.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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