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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and .5, 1, and 2 hours post-injection
Awards & highlights
ARIA Trial 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.Check my eligibility
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.See study design
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.
ARIA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 60 and 80 years old.
ARIA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and .5, 1, and 2 hours post-injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and .5, 1, and 2 hours post-injection
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreOther outcome measures
Attentional Bias Task
Behavioral Indices of Reward Motivation and Sensitivity with Incentive Delay Tasks
Behavioral Indices of Reward Sensitivity - EEfRT
+8 moreSide effects data
From 2016 Phase 1 & 2 trial • 10 Patients • NCT00923910100%
Platelets-low
80%
Glucose, serum-low (hypoglycemia)
80%
Neutrophils/granulocytes (ANC/AGC) - low
80%
Rash/desquamation
80%
Leukocytes (total WBC) - low
80%
Pruritis/itching
80%
Hemoglobin-low
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
60%
Sodium, serum-low (hyponatremia)
60%
ALT, SGPT (serum glutamic pyruvic transaminase) - high
40%
Bicarbonate, serum low
40%
Albumin, serum low (hypoalbuminemia)
40%
Cough
40%
Magnesium, serum high (hypermagnesemia)
40%
Magnesium, serum low (hypomagnesemia)
40%
Nausea
40%
Potassium, serum-low (hypokalemia)
40%
Glucose (serum -high (hyperglycemia)
40%
Pain: Head/Headache
40%
Supraventricular and nodal arrhythmia: sinus tachycardia
40%
Mood alteration:anxiety
40%
Pain: throat/pharynx/larynx
40%
PTT (partial thromboplastin time)
40%
Calcium, serum-low (hypocalcemia)
40%
Diarrhea
20%
Febrile neutropenia
20%
Insomnia
20%
Hemorrhage, pulmonary/upper respiratory: Nose
20%
Hypotension
20%
Fatigue (asthenia, lethargy, malaise)
20%
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
20%
Hepatobiliary/pancreas- Other, Specify - non-alcoholic Steatoheptits
20%
Infection with normal ANC or Grade 1 or 2 neutriphils:lung (pneumonia)
20%
GGT (gamma-Glutamyl transpeptidase)
20%
Dry eye syndrome
20%
Esophagitis
20%
Iron overload
20%
Ocular/Visual - Other, Specify - Eye drainage
20%
Pain: Eye
20%
Supraventricular and nodal arrhythmia: sinus bradycardia
20%
Pain:pain NOS
20%
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
20%
Anorexia
20%
Allergy/Immunology - Other, Specify - allergy to Sorbaview
20%
Coagulation - Other, Specify - PT, prolonged
20%
Pain:Joint
20%
Rigors/chills
20%
Striae
20%
Sweating (diaphoresis)
20%
Triglyceride, serum high (hypertriglyceridemia)
20%
Uric acid, serum high (hyperuricemia)
20%
Urinary frequency/urgency
20%
Vision-blurred vision
20%
Potassium, serum-high (hyperkalemia)
20%
Phosphate, serum low (hypophosphatemia)
20%
Pain: chest wall
20%
Pain: neck
20%
Infection with normal ANC or Grade 1 or 2 neutrophils:lung (pneumonia)
20%
Infection with normal ANC or Grade 1 or 2 neutrophils: upper airway NOS
20%
Pain:muscle
20%
Proteinuria
20%
Sodium, serum-high (hypernatremia)
20%
Infection with unknown ANC:sinus
20%
Bilirubin (hyperbilirubinemia)
20%
Cholesterol, serum-high (hypercholesteremia)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Recipients
ARIA 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
~500
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
1,530 Previous Clinical Trials
10,278,122 Total Patients Enrolled
101 Trials studying Depression
48,363 Patients Enrolled for Depression
National Institute on Aging (NIA)NIH
1,672 Previous Clinical Trials
28,018,583 Total Patients Enrolled
34 Trials studying Depression
28,187 Patients Enrolled for Depression
Chloe C Boyle, PHDPrincipal InvestigatorUniversity of California, Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used recreational drugs, as shown by a urine test.You have tried to harm yourself or have been hospitalized for mental health reasons in the past.You drink a lot of caffeine every day (more than 600 mg), which can affect certain substances in the body that cause inflammation.I am between 60 and 80 years old.I have a current diagnosis of sleep apnea or nocturnal myoclonus.I have used drugs that affect my immune system.You are currently a smoker.Revised Criterion: Half of the participants (40 out of the total) will be those who have significant anxiety, which is determined by a score of 5 or higher on the GAD-7 questionnaire.Half of the participants (40 out of the total) will be those who have very low anxiety, as indicated by a GAD-7 score of less than 5.I regularly use pain medication, including opioids.I have a sleep disorder affecting my sleep-wake cycle.I have a history of severe allergies, autoimmune, liver, or other chronic diseases.I have other health issues like heart disease, stroke, Parkinson's, or chronic pain.I have a long-term infection that causes inflammation.I have not had an infection in the last two weeks.I have an autoimmune disorder like rheumatoid arthritis.I regularly use medication for heart-related conditions.You have any important abnormal results on your screening blood tests.You have a body mass index (BMI) above 35 because obesity can affect how your body responds to inflammation.You have important irregularities in your heart's electrical activity as shown on an electrocardiogram.I currently use or have used hormone medications, including steroids.I regularly use non-steroid anti-inflammatory drugs.You have fainted during blood draws in the past.You have worked night shifts or changed time zones by more than 3 hours in the last 6 weeks.You don't have any significant mental health conditions other than anxiety.You have a long-term mental or physical illness, except for anxiety.I haven't taken any prescription drugs like steroids or painkillers in the last 6 months.I do not have claustrophobia.You have metal in your body.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Endotoxin
Awards:
This trial has 0 awards, including: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 this clinical trial currently seeking participants?
"According to clinicaltrials.gov, this study is still enrolling individuals and was first made available on October 1st 2022. It has since had a refresh in terms of information on August 23rd 2022."
Answered by AI
What is the principal aim of this experiment?
"This trial will be conducted for a two-hour duration, during which the primary outcome - Neural Indices of Reward Motivation - Effort-Based Decision Making - will be measured. As secondary goals, this clinical study also looks to measure Social Incentive Delay Task's neural indices of reward motivation for close social rewards; Monetary Incentive Delay Task's neural indices of monetary reward sensitivity; and Social Incentive Delay task's neural indices of reward sensitivity for close social rewards."
Answered by AI
Has Endotoxin obtained the necessary endorsement from the Food and Drug Administration?
"As the study is in its earliest phase, there has been only minimal data collection on Endotoxin's safety and efficacy. This earned it a score of 1 out of 3."
Answered by AI
Are individuals aged 25 and above accepted into this research project?
"To be considered for the study, individuals must fall between the age ranges of 60 to 80. Conversely, there are 302 trials available to those under 18 and 1,593 open studies that cater to seniors over 65 years old."
Answered by AI
How many participants have taken part in this experiment thus far?
"Yes, according to the data posted on clinicaltrials.gov this medical trial launched in October of 2022 and is ongoing - with its most recent update occurring at the end of August. 80 participants are expected to be recruited from a single location."
Answered by AI
What are the prerequisites for enrolment in this clinical investigation?
"In order to join this trial, applicants must suffer from anhedonia and be between the ages of 60 and 80. The research team is looking for a total of eighty individuals to take part in the experiment."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Norman Cousins Center for Psychoneuroimmunology, University of California, Los Angeles
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