Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 1:03 PM
Study NCT ID:
NCT04823260
Status:
COMPLETED
Last Update Posted:
2021-10-01
First Post:
2021-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy and Safety of NMN as an Anti-ageing Supplement in Middle Aged and Older (40-65 Years) Adults
Sponsor:
Abinopharm, Inc
Organization:
Study Overview
Official Title:
A Multi Center Two Part Study to Evaluate the Efficacy and Safety of NMN as an Anti-ageing Supplement in Middle Aged and Older (40-65 Years) Adults
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It will be a two-part study. Part I will be six arms; randomized, double blind, parallel design, placebo-controlled dose ranging study. Part II will be open-label single dose study at the highest dose.
A total of 90 Subjects (Part 1 \& Part 2) will be enrolled in the study. The Part 1 group subjects (80 Subjects) shall be randomly distributed between the six arms, i.e. 20 Subjects each in IP arms, and 7, 7 and 6 subjects in corresponding placebo arms.
All Part 2 Group subjects (10 Subjects) will be assigned into the cluster where all receive the maximum NMN dose (900 mg)
A total of 90 Subjects (Part 1 \& Part 2) will be enrolled in the study. The Part 1 group subjects (80 Subjects) shall be randomly distributed between the six arms, i.e. 20 Subjects each in IP arms, and 7, 7 and 6 subjects in corresponding placebo arms.
All Part 2 Group subjects (10 Subjects) will be assigned into the cluster where all receive the maximum NMN dose (900 mg)
Detailed Description:
It will be a two-part study. Part I will be six arms; randomized, double blind, parallel design, placebo-controlled dose ranging study. Part II will be open-label single dose study at the highest dose.
Total number of Subjects is N = 90 (Part 1 \& Part 2) Part I: six arms Arm A = 300 mg NMN supplement (n = 20) Arm B = Placebo of 300 mg NMN supplement (n = 07) Arm C = 600 mg NMN supplement (n = 20) Arm D = Placebo of 600 mg NMN supplement (n = 07) Arm E = 900 mg NMN supplement (n = 20) Arm F = Placebo of 900 mg NMN supplement (n = 06) Part II 900 mg NMN supplement (n = 10) Duration of Protocol Therapy = 60 Days Study Population= Middle aged or older male or female subjects (40-65 years)
The duration of each subject's participation in the study will be of 60 days. Scheduled study visits will include:
* Visit 1 (Screening, Day -4)
* Visit 2 (Baseline/Randomization visit, Day 1)
* Visit 3 (Day 30).
* Visit 4 (End of study, Day 60) A window (± 2 days) will be considered acceptable for each scheduled visit following the baseline visit.
During Visit 1 (Screening), informed consent will be obtained before any study procedures take place. After subject has consented, medical history will then be documented, including the concomitant medications (if any). Physical examination and ECG will be carried out for all subjects. Subjects' vital signs will be recorded along with pulse pressure (PP). Their laboratory investigations like Hematology, Clinical chemistry and Urinalysis will be done. They will be symptomatically assessed for COVID-19. They shall undergo the screening procedure by inclusion and exclusion criteria. Subject's demography data will be collected. They will be given instructions for the next visit.
At Visit 2 (Day 1, Baseline visit), eligibility confirmation will be done, and each enrolled subject will be randomly assigned in double-blind fashion, in 1:1 ratio to the test product or the Placebo or to the maximum dose group (Part 2 subjects). Blinded investigational product will be dispensed to subjects for Part 1 who meet all the inclusion and none of the exclusion criteria. Part 2 group subjects will be dispensed with maximum dose of NMN (900mg) without any blinding. Subjects will be instructed to take two to six capsules (depending on thegroups that the subjects fall under) of the either placebo or NMN once a day with ambient temperature water before breakfast. They shall be recording the dosing details in subject diaries. The Investigational Product will be taken by the subject at home right from the first dose. Subjects will be evaluated through SF-36 questionnaire for their health. They will be required to answer the list of questions pertaining to their health. (PI, CRC or site staff will fill SF-36 questionnaire in visit 2, 3 and 4 by asking the subject). All the baseline assessments for efficacy will be performed.
At visit 3 (Day 30) and visit 4 (Day 60), subjects will return to the clinic to review and collect subjects' diaries, safety data and medication reconciliation. Efficacy and safety assessments will be done at both the visits.
Subjects will be asked to bring their subject diaries and used/unused Investigational Product every time they visit the site(empty bottles in case of used IP). Enough quantity of Investigational Product will be dispensed every visit. Subjects' vital signs will be recorded along with pulse pressure (PP) at all visits. Adverse event assessment and concomitant assessment will be done at each visit along with compliance with study supplement administration.
End points:
Primary efficacy endpoints (Part I ) Blood cellular NAD/NADH concentration in serum \[ Time Frame: Baseline, 1 month and 2 Months\] Six minutes walking endurance test \[ Time Frame: Baseline, 1 month and 2 Months\] SF-36 questionnaire \[ Time Frame: Baseline, 1 month and 2 Months\]
Secondary endpoints :
1. To compare the safety of NMN versus placebo \[ Time Frame: Baseline to 2 Months\]
2. Monitoring and documentation of number and type of adverse events including changes on laboratory parameter (blood chemistry, lipid profile, LFT and RFT)
3. To compare the tolerability of NMN versus placebo \[ Time Frame: Baseline to 2 Months\] Tolerability: Number of participants that dropout due to adverse events including lab values
4. Monitoring and documentation of subject dropout due to adverse events
5. To compare the safety of the different NMN doses \[ Time Frame: Baseline to 2 Months\]
6. Monitoring and documentation of number and type of adverse events including changes on laboratory parameter (blood chemistry, lipid profile, LFT and RFT)
7. To compare the tolerability different NMN doses \[ Time Frame: Baseline to 2 Months\] Tolerability: Number of participants that dropout due to adverse events including lab values Monitoring and documentation of subject
Exploratory endpoints :
1. BMI
2. HOMA (Homeostatic model assessment) Biological Age using Aging.Ai 3.0 calculator \[ Time Frame: Baseline to 2 Months\]
Primary Endpoints : (Part II)
Evaluation will include the following parameters:
1. Telomerase test results \[ Time Frame: Baseline and 2 Months\]
2. SF-36 questionnaire \[ Time Frame: Baseline and 2 Months\]
Secondary endpoint:
1. Safety of NMN \[ Time Frame: Baseline to 2 Months\]
2. Monitoring and documentation of number and type of adverse events including changes on laboratory parameter (blood chemistry, lipid profile, LFT and RFT, CEA test)
Total number of Subjects is N = 90 (Part 1 \& Part 2) Part I: six arms Arm A = 300 mg NMN supplement (n = 20) Arm B = Placebo of 300 mg NMN supplement (n = 07) Arm C = 600 mg NMN supplement (n = 20) Arm D = Placebo of 600 mg NMN supplement (n = 07) Arm E = 900 mg NMN supplement (n = 20) Arm F = Placebo of 900 mg NMN supplement (n = 06) Part II 900 mg NMN supplement (n = 10) Duration of Protocol Therapy = 60 Days Study Population= Middle aged or older male or female subjects (40-65 years)
The duration of each subject's participation in the study will be of 60 days. Scheduled study visits will include:
* Visit 1 (Screening, Day -4)
* Visit 2 (Baseline/Randomization visit, Day 1)
* Visit 3 (Day 30).
* Visit 4 (End of study, Day 60) A window (± 2 days) will be considered acceptable for each scheduled visit following the baseline visit.
During Visit 1 (Screening), informed consent will be obtained before any study procedures take place. After subject has consented, medical history will then be documented, including the concomitant medications (if any). Physical examination and ECG will be carried out for all subjects. Subjects' vital signs will be recorded along with pulse pressure (PP). Their laboratory investigations like Hematology, Clinical chemistry and Urinalysis will be done. They will be symptomatically assessed for COVID-19. They shall undergo the screening procedure by inclusion and exclusion criteria. Subject's demography data will be collected. They will be given instructions for the next visit.
At Visit 2 (Day 1, Baseline visit), eligibility confirmation will be done, and each enrolled subject will be randomly assigned in double-blind fashion, in 1:1 ratio to the test product or the Placebo or to the maximum dose group (Part 2 subjects). Blinded investigational product will be dispensed to subjects for Part 1 who meet all the inclusion and none of the exclusion criteria. Part 2 group subjects will be dispensed with maximum dose of NMN (900mg) without any blinding. Subjects will be instructed to take two to six capsules (depending on thegroups that the subjects fall under) of the either placebo or NMN once a day with ambient temperature water before breakfast. They shall be recording the dosing details in subject diaries. The Investigational Product will be taken by the subject at home right from the first dose. Subjects will be evaluated through SF-36 questionnaire for their health. They will be required to answer the list of questions pertaining to their health. (PI, CRC or site staff will fill SF-36 questionnaire in visit 2, 3 and 4 by asking the subject). All the baseline assessments for efficacy will be performed.
At visit 3 (Day 30) and visit 4 (Day 60), subjects will return to the clinic to review and collect subjects' diaries, safety data and medication reconciliation. Efficacy and safety assessments will be done at both the visits.
Subjects will be asked to bring their subject diaries and used/unused Investigational Product every time they visit the site(empty bottles in case of used IP). Enough quantity of Investigational Product will be dispensed every visit. Subjects' vital signs will be recorded along with pulse pressure (PP) at all visits. Adverse event assessment and concomitant assessment will be done at each visit along with compliance with study supplement administration.
End points:
Primary efficacy endpoints (Part I ) Blood cellular NAD/NADH concentration in serum \[ Time Frame: Baseline, 1 month and 2 Months\] Six minutes walking endurance test \[ Time Frame: Baseline, 1 month and 2 Months\] SF-36 questionnaire \[ Time Frame: Baseline, 1 month and 2 Months\]
Secondary endpoints :
1. To compare the safety of NMN versus placebo \[ Time Frame: Baseline to 2 Months\]
2. Monitoring and documentation of number and type of adverse events including changes on laboratory parameter (blood chemistry, lipid profile, LFT and RFT)
3. To compare the tolerability of NMN versus placebo \[ Time Frame: Baseline to 2 Months\] Tolerability: Number of participants that dropout due to adverse events including lab values
4. Monitoring and documentation of subject dropout due to adverse events
5. To compare the safety of the different NMN doses \[ Time Frame: Baseline to 2 Months\]
6. Monitoring and documentation of number and type of adverse events including changes on laboratory parameter (blood chemistry, lipid profile, LFT and RFT)
7. To compare the tolerability different NMN doses \[ Time Frame: Baseline to 2 Months\] Tolerability: Number of participants that dropout due to adverse events including lab values Monitoring and documentation of subject
Exploratory endpoints :
1. BMI
2. HOMA (Homeostatic model assessment) Biological Age using Aging.Ai 3.0 calculator \[ Time Frame: Baseline to 2 Months\]
Primary Endpoints : (Part II)
Evaluation will include the following parameters:
1. Telomerase test results \[ Time Frame: Baseline and 2 Months\]
2. SF-36 questionnaire \[ Time Frame: Baseline and 2 Months\]
Secondary endpoint:
1. Safety of NMN \[ Time Frame: Baseline to 2 Months\]
2. Monitoring and documentation of number and type of adverse events including changes on laboratory parameter (blood chemistry, lipid profile, LFT and RFT, CEA test)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: