An observational study in Aging, sponsored by AgelessRx. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by AgelessRx · Observational
This retrospective, observational study will assess the health status of short- and long-term low-dose naltrexone (LDN) users.
Long-term (>5 years), intermediate-term (1-5 years), and short-term low-dose naltrexone (LDN) users (\<12 months) will be contacted for a retrospective, observational assessment of their health status. Participants will be asked to complete a series of questionnaires assessing their quality of life, general physical and mental health, family history, the occurrence of age-related diseases, and immune status. Additionally, blood tests for immune and longevity markers will be optional for a subset of participants.
AgelessRx is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Eligible long-term (>5 years), intermediate-term (1-5 years), and short-term (\<12 months) LDN users
Exclusion Criteria:
Participants who have been using LDN for over 5 years
Drug: low-dose naltrexone
Participants who have been using LDN for at least 1 year, but shorter than 5 years.
Drug: low-dose naltrexone
Participants who have been using LDN for less than a year. This group will serve as the control group.
Drug: low-dose naltrexone
LDN doses \<20 mg/day
Also known as: LDN
Quality of life score
The short-form (SF)-36 Questionnaire generates scores in the categories: physical function, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Scores up to maximum 100, with higher scores representing better quality of life
Time frame: At enrollment
Immune Status
Immune Status Questionnaire (ISQ) to define a measure of perceived immune status, consists of seven representative immune-associated symptoms and diseases. The Immune Status Questionnaire scores respondents out of 10, with 10 being a better outcome and lower scores worse outcome.
Time frame: At enrollment
General health and family history
Standard questions assessing family history, and information about the dosing, duration of use, reasons for taking LDN, age, sex, weight, length, smoking and alcohol use history, substance abuse history, physical activity, other medications, and side effects of the drug, and other questions related to health and medical history.
Time frame: At enrollment
Levine's phenotypic age
Levine's phenotypic age will be calculated on basis of blood markers for age-associated diseases (glucoregulatory markers, lipids), as well as markers of inflammation
Time frame: At enrollment
CD4/CD8 ratio
Peripheral blood CD4 vs CD8 T cell ratio in cells/mm3
Time frame: At enrollment
CMV IgG
Peripheral blood cytomegalovirus (CMV) IgG antibodies in U/mL
Time frame: At enrollment
hsCRP
Peripheral blood human serum C-reactive protein (hsCRP) concentration in mg/L
Time frame: At enrollment
IL-6
Peripheral blood serum interleukin-6 (IL-6) concentration in pg/L
Time frame: At enrollment
TNFɑ
Peripheral blood serum tumor-necrosis factor alpha (TNFɑ) concentration in pg/L
Time frame: At enrollment
Methylation age clock testing
DNA methylation array of a blood sample
Time frame: At enrollment
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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