AgingNCT05307627
The Effects of Low Dose Naltrexone (LDN) on Diseases of Aging
An observational study of Aging, run by AgelessRx at 1 site in United States.
Trial summary
This retrospective, observational study will assess the health status of short- and long-term low-dose naltrexone (LDN) users. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Aging
- What is being tested?
- low-dose naltrexone
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2022to 14 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Adult, Older adult
Study population: Eligible long-term (>5 years), intermediate-term (1-5 years), and short-term (<12 months) LDN users
Who may be able to join
- Adults (aged 18-120)
- Any sex
- Any ethnicity
- Taking LDN
- Willing to complete health questionnaires
- Technologically competent to complete web forms
- Subgroup: willing to undergo blood testing
Who cannot join
- LDN doses over 20 mg/day
- Terminal cancer patients (defined as stage IV and/or with a life expectancy of 12 months or less)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Low Dose Naltrexone (LDN) on Diseases of Aging - A Retrospective Cross-sectional Study Into Off-label Use of LDN
This retrospective, observational study will assess the health status of short- and long-term low-dose naltrexone (LDN) users.
Read the detailed description
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.
- Conditions
- Aging
- Being tested
- low-dose naltrexone
- Keywords
- low-dose naltrexone, longevity, health status, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose naltrexoneDrug
Also called LDN
LDN doses <20 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Long-term (>5 years) LDN users | Participants who have been using LDN for over 5 years Receives: Drug: low-dose naltrexone | |
| intermediate-term (1-5 years) LDN users | Participants who have been using LDN for at least 1 year, but shorter than 5 years. Receives: Drug: low-dose naltrexone | |
| short-term (<12 months) LDN users | Participants who have been using LDN for less than a year. This group will serve as the control group. Receives: Drug: low-dose naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: At enrollment
Secondary outcomes (8)
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.
Measured: 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
Measured: At enrollment
CD4/CD8 ratio
Peripheral blood CD4 vs CD8 T cell ratio in cells/mm3
Measured: At enrollment
CMV IgG
Peripheral blood cytomegalovirus (CMV) IgG antibodies in U/mL
Measured: At enrollment
hsCRP
Peripheral blood human serum C-reactive protein (hsCRP) concentration in mg/L
Measured: At enrollment
IL-6
Peripheral blood serum interleukin-6 (IL-6) concentration in pg/L
Measured: At enrollment
TNFɑ
Peripheral blood serum tumor-necrosis factor alpha (TNFɑ) concentration in pg/L
Measured: At enrollment
Methylation age clock testing
DNA methylation array of a blood sample
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start14 Mar 2022
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Why it stopped: Technological barriers are affecting the participant response experience.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AgelessRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sajad Zalzala, MD, Principal investigator, AgelessRx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307627
- Sponsor's protocol ID
- ALRx002
- Status last verified
- Aug 2024
- First submitted
- 7 Mar 2022
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Low Dose Naltrexone (LDN) on Diseases of Aging - A Retrospective Cross-sectional Study Into Off-label Use of LDN
- ClinicalTrials.gov ID
- NCT05307627
- Acronym / sponsor ID
- ALRx002
- Conditions
- Aging
- Keywords
- low-dose naltrexone, longevity, health status, quality of life
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Technological barriers are affecting the participant response experience.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AgelessRxIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective, observational study will assess the health status of short- and long-term low-dose naltrexone (LDN) users.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Long-term (>5 years) LDN users | – | Drug: low-dose naltrexoneParticipants who have been using LDN for over 5 years |
| intermediate-term (1-5 years) LDN users | – | Drug: low-dose naltrexoneParticipants who have been using LDN for at least 1 year, but shorter than 5 years. |
| short-term (<12 months) LDN users | – | Drug: low-dose naltrexoneParticipants who have been using LDN for less than a year. This group will serve as the control group. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligible long-term (>5 years), intermediate-term (1-5 years), and short-term (<12 months) LDN users
Key inclusion criteria (7 listed)
- Adults (aged 18-120)
- Any sex
- Any ethnicity
- Taking LDN
- Willing to complete health questionnaires
Key exclusion criteria (2 listed)
- LDN doses over 20 mg/day
- Terminal cancer patients (defined as stage IV and/or with a life expectancy of 12 months or less)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-dose naltrexoneAlso: LDNLDN doses <20 mg/day | Drug | Long-term (>5 years) LDN users, intermediate-term (1-5 years) LDN users, short-term (<12 months) LDN users |
Primary outcome
Quality of life score
Time frame: At enrollment
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
Immune Status
Time frame: At enrollment
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.
8 secondary outcomes
General health and family history
Time frame: At enrollment
Levine's phenotypic age
Time frame: At enrollment
CD4/CD8 ratio
Time frame: At enrollment
CMV IgG
Time frame: At enrollment
hsCRP
Time frame: At enrollment
IL-6
Time frame: At enrollment
TNFɑ
Time frame: At enrollment
Methylation age clock testing
Time frame: At enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sajad Zalzala, MD principal investigator
AgelessRx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by AgelessRx at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life score (time frame: At enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.