Improving Physical Function in Older Adults Using an Anti-inflammation Drug: The RIGHT Study

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Anne B. Newman
• Collaborator: CSL Behring

Criteria

Inclusion Criteria:

• Persons aged ≥ 70 years at time of randomization

• Gait speed ≥ 0.44 m/sec to < 1.0 m/sec

• IL-6 level ≥ 2.5 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

Exclusion Criteria:

• 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, follow oral instructions, and which may limit feasibility of 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

• Self-reported uncontrolled diabetes or fasting glucose > 200 mg/dL

• Cancer: Stage 1 cancer (including melanoma and non-melanoma skin cancers) within the past 5 years, 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

• Platelet count outside normal range or < 125 x109/L

• Hemoglobin outside normal sex-specific range

• Total Cholesterol > 300 mg/dL or Triglycerides > 400 mg/dL

• Dialysis treatment or chronic renal insufficiency defined as MDRD eGFR < 45 ml/min/(1.73) m2

• History of diverticular disease or GI perforation

• History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies

• Current use of Warfarin (Coumadin, Jantoven)

• Unable or unwilling to provide informed consent

• Current participation in another interventional study (including trials of exercise, diet, or investigational drugs)

• A psychiatric disorder that is impairing ability to consent or comply with requirements of the trial

• Residence or travel outside of the study area for more than one month during the study or planning to move out of the area in the next six months.

• Other conditions which at the discretion of the site PI which would make participation unsafe or inappropriate (logistic, behavioral, medical)