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Inflammation's Impact on Reward Response in Aging and Anxiety (ARIA Trial)

Phase 1
Recruiting
Led By Chloe C Boyle, PHD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants will be aged 60 to 80 years.
Be older than 18 years old
Must not have
Sleep Disorders: Current history of sleep apnea or nocturnal myoclonus;
Current and/or past regular use of immune modifying drugs that target specific immune responses such as cytokine antagonists;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and .5, 1, and 2 hours post-injection

Summary

This trial will look at whether older adults with anxiety symptoms experience a loss of pleasure or motivation when exposed to inflammation. This will be evaluated using self-report questionnaires, computer tasks, and during a brain scan.

Who is the study for?
This trial is for adults aged 60-80, with or without anxiety. Participants must be in good health and not have severe chronic diseases, autoimmune disorders, uncontrolled medical conditions, a BMI over 35, or use certain medications like steroids or anti-inflammatories. They can't have a history of serious psychiatric issues or current sleep disorders.
What is being tested?
The study tests how older adults with varying levels of anxiety respond to an experimental inflammation challenge (using Endotoxin vs Placebo). It measures changes in pleasure and motivation through questionnaires, computer tasks, and brain scans.
What are the potential side effects?
Potential side effects from the endotoxin may include temporary flu-like symptoms such as fever, chills, headache, muscle pain. The placebo should not cause any side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 60 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a current diagnosis of sleep apnea or nocturnal myoclonus.
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I have used drugs that affect my immune system.
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I regularly use pain medication, including opioids.
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I have a sleep disorder affecting my sleep-wake cycle.
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I have a history of severe allergies, autoimmune, liver, or other chronic diseases.
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I have an autoimmune disorder like rheumatoid arthritis.
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I currently use or have used hormone medications, including steroids.
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I do not have claustrophobia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and .5, 1, and 2 hours post-injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and .5, 1, and 2 hours post-injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neural Indices of Monetary Reward Sensitivity during Effort-Based Decision Making
Neural Indices of Reward Motivation - Anticipatory Reward Response
Neural Indices of Reward Motivation - Effort-Based Decision Making
+1 more
Secondary study objectives
Behavioral Indices of Reward Motivation - Effort-Based Decision Making
Behavioral Indices of Reward Sensitivity and Learning - Probabilistic Reward Task
Behavioral Indices of Reward motivation - close other social reward
+8 more
Other study objectives
Attentional Bias Task
Behavioral Indices of Reward Motivation and Sensitivity with Incentive Delay Tasks
Behavioral Indices of Reward Sensitivity - EEfRT
+8 more

Side effects data

From 2016 Phase 1 & 2 trial • 10 Patients • NCT00923910
100%
Platelets-low
80%
Glucose, serum-low (hypoglycemia)
80%
Hemoglobin-low
80%
Pruritis/itching
80%
Leukocytes (total WBC) - low
80%
Rash/desquamation
80%
Neutrophils/granulocytes (ANC/AGC) - low
60%
ALT, SGPT (serum glutamic pyruvic transaminase) - high
60%
Sodium, serum-low (hyponatremia)
60%
AST, SGOT (serum glutamic oxaloacetic transaminase) - high
60%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0x10e9/L)
60%
Pain: Abdomen NOS
40%
Supraventricular and nodal arrhythmia: sinus tachycardia
40%
Mood alteration:anxiety
40%
Albumin, serum low (hypoalbuminemia)
40%
Glucose (serum -high (hyperglycemia)
40%
Bicarbonate, serum low
40%
Diarrhea
40%
PTT (partial thromboplastin time)
40%
Magnesium, serum high (hypermagnesemia)
40%
Magnesium, serum low (hypomagnesemia)
40%
Pain: Head/Headache
40%
Potassium, serum-low (hypokalemia)
40%
Cough
40%
Nausea
40%
Pain: throat/pharynx/larynx
40%
Calcium, serum-low (hypocalcemia)
20%
Phosphate, serum low (hypophosphatemia)
20%
Supraventricular and nodal arrhythmia: sinus bradycardia
20%
Infection with normal ANC or Grade 1 or 2 neutrophils:lung (pneumonia)
20%
Potassium, serum-high (hyperkalemia)
20%
Pain: chest wall
20%
Proteinuria
20%
Triglyceride, serum high (hypertriglyceridemia)
20%
Sodium, serum-high (hypernatremia)
20%
Dry eye syndrome
20%
Infection with normal ANC or Grade 1 or 2 neutriphils:lung (pneumonia)
20%
GGT (gamma-Glutamyl transpeptidase)
20%
Allergy/Immunology - Other, Specify - allergy to Sorbaview
20%
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
20%
Insomnia
20%
Rigors/chills
20%
Pain: neck
20%
Cholesterol, serum-high (hypercholesteremia)
20%
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
20%
Hypotension
20%
Fatigue (asthenia, lethargy, malaise)
20%
Coagulation - Other, Specify - PT, prolonged
20%
Hemorrhage, pulmonary/upper respiratory: Nose
20%
Hepatobiliary/pancreas- Other, Specify - non-alcoholic Steatoheptits
20%
Esophagitis
20%
Febrile neutropenia
20%
Anorexia
20%
Iron overload
20%
Infection with unknown ANC:sinus
20%
Pain:muscle
20%
Pain:pain NOS
20%
Ocular/Visual - Other, Specify - Eye drainage
20%
Pain: Eye
20%
Striae
20%
Uric acid, serum high (hyperuricemia)
20%
Urinary frequency/urgency
20%
Vision-blurred vision
20%
Infection with normal ANC or Grade 1 or 2 neutrophils: upper airway NOS
20%
Pain:Joint
20%
Sweating (diaphoresis)
20%
Bilirubin (hyperbilirubinemia)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Recipients

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EndotoxinExperimental Treatment1 Intervention
Endotoxin 0.8 ng/kg body weight
Group II: PlaceboPlacebo Group1 Intervention
same volume of 0.9% saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endotoxin
2008
Completed Phase 4
~660

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,569 Previous Clinical Trials
10,314,255 Total Patients Enrolled
106 Trials studying Depression
49,512 Patients Enrolled for Depression
National Institute on Aging (NIA)NIH
1,804 Previous Clinical Trials
28,194,859 Total Patients Enrolled
40 Trials studying Depression
31,926 Patients Enrolled for Depression
Chloe C Boyle, PHDPrincipal InvestigatorUniversity of California, Los Angeles

Media Library

Endotoxin Clinical Trial Eligibility Overview. Trial Name: NCT05363527 — Phase 1
Depression Research Study Groups: Placebo, Endotoxin
Depression Clinical Trial 2023: Endotoxin Highlights & Side Effects. Trial Name: NCT05363527 — Phase 1
Endotoxin 2023 Treatment Timeline for Medical Study. Trial Name: NCT05363527 — Phase 1
~16 spots leftby Mar 2026
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