Improving Physical Function in Older Adults Using an Anti-inflammation Drug: The RIGHT Study
Completed · Phase 2 · Has a placebo group
Conditions studied: Inflammation, Frailty
In brief
The goal of this clinical trial is to learn about the effects of inflammation-lowering therapy on mobility and disability in older adults. The main questions it aims to answer are: * Will therapy improve walking speed/pace? * Will therapy improve levels of blood inflammation markers and other indicators of physical, cognitive and immune function? Participants will be asked to receive injections of drug or placebo every 4 weeks for 24 weeks. They will also be asked to undergo testing that assesses physical function, thinking ability and brain health, breathing capacity, and blood vessel stiffness, and will have blood samples collected to measure immune function and to create a bank of samples for future testing. Comparisons will be made between those who receive drug and those who receive placebo.
Key facts
- Study ID
- NCT05727384
- Run by
- Anne B. Newman
- People needed
- 29
- Starts
- 2023-08-01
- Expected to finish
- 2026-05-26
- Last updated by the study team
- 2026-06-11
Who can join
Age: 70 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Persons aged ≥ 70 years at time of randomization
- Gait speed ≥ 0.44 m/sec to < 1.0 m/sec or BMI ≥ 28 kg/m2
- IL-6 level ≥ 2.0 pg/ml but < 30.0 pg/ml
- Self-reported difficulty walking ¼ mile or climbing 10 steps
- Self-reported ability to walk 400 meters (about 2-3 blocks), unassisted
- Self-reported vaccinations for COVID-19, Influenza and pneumococcal pneumonia up to date per current CDC guidelines
You may not qualify if…
- Advanced neurologic disorder such as dementia, Parkinson's disease, amytrophic lateral sclerosis, or multiple sclerosis that would impact the ability to improve on functional assessments
- Resident in a nursing home
- Severe hearing or vision loss that would impair participant's ability to complete questionnaires or follow oral instructions, and which may limit feasibility of performing functional assessments
- Acute infections (including but not limited to common cold virus, shingles virus, bronchitis, skin infection, urinary tract infection, tooth abscess) within 60 days of randomization
- Chronic infection (including but not limited to):
- History of active TB or evidence of latent TB based on a positive PPD skin test, positive Quantiferon TB-Gold test, or a history of old or latent TB on chest x-ray
- History of Hepatitis B or Hepatitis C
- Previous diagnosis of Human Immunodeficiency Virus (HIV) or Acquired ImmunoDeficiency Syndrome (AIDS)
- Inflammatory or autoimmune disease (including but not limited to rheumatoid arthritis, lupus, or inflammatory bowel disease, such as ulcerative colitis or Crohn's disease)
- Immunization with a live/attenuated vaccine within 2 months prior to randomization (e.g., viral: measles vaccine, mumps vaccine, rubella vaccine, live attenuated influenza vaccine, live attenuated chicken pox or shingles vaccine, smallpox vaccine, oral polio vaccine (Sabin), rotavirus vaccine, and yellow fever vaccine. Bacterial: BCG vaccine, oral typhoid vaccine and epidemic typhus vaccine)
- Current use of chronic immune modulating medications such as corticosteroids, monoclonal antibodies, janus kinase inhibitors, calcineurin inhibitors, mTOR inhibitors, IMDH inhibitors, or biologics
- Admitted for an overnight hospitalization in the last 6 months
- Open-chest heart surgery (including, but not limited to, coronary artery bypass graft surgery or aortic valve surgery) in the past 6 months
- Anticipating major surgery (including, but not limited to, chest, abdomen, or joint surgery) in the next 6 months
- Deep vein thrombosis or pulmonary embolus in the past 6 months
- Severe lung disease or heart disease that requires oxygen use anytime during the day (including, but not limited to, use only during activity, use only at night or use all day)
- Tobacco use (including cigarettes, cigar, pipe, or vaping) or inhaled cannabis in the past 6 months
- Current consumption of > 14 alcoholic drinks per week
- History of substance abuse including cocaine, methamphetamine, opioids, or narcotics; any use of cannabis
- Uncontrolled diabetes, noncompliant with treatment or fasting glucose > 250 mg/dL
- Cancer: Stage 1 cancer (including melanoma skin cancers) within the past 5 years, other than adequately treated (fully excised and recovered from surgery based on the judgement of a study MD) basal and/or squamous cell skin cancer, or stage 2 or stage 3 cancer within 10 years, or any history of stage 4 (metastatic) cancer
- Inability to get a normal systolic blood pressure reading (between 100-180) at two consecutive visits prior to randomization (must be at least 1 day apart)
- ALT, AST, or Total Bilirubin > Upper Limit of Normal (ULN)
- Absolute Neutrophil Count outside normal range or < 1.5 x109/L
- White Blood Count outside normal range
Where it is running
- University of Pittsburgh, Health Studies Research Center — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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