Trial Outcomes & Findings for Network-Level Mechanisms for Preclinical Alzheimer's Disease Development (NCT NCT03461861)
NCT ID: NCT03461861
Last Updated: 2023-07-03
Results Overview
The seed-based functional connectivity strengths of the hippocampus network and the default mode network will be employed to measure the changes between AGB101 and Placebo perturbation. The functional connectivity strengths will be measured with the median of the Pearson cross-correlation coefficients over entire brain regions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
2 weeks after treatment between AGB101 and Placebo
Results posted on
2023-07-03
Participant Flow
Participant milestones
| Measure |
AGB101 220 mg, Then Placebo
AGB101 220 mg/day capsule, once daily dosing for 2 weeks. After a 4 week washout, to be followed by Placebo, given as a capsule, once daily dosing for 2 weeks.
AGB101 220 mg: AGB101 oral dose of 220 mg/day capsule, given as once-daily dosing.
Placebo: Placebo, oral capsule given once-daily.
|
Placebo, Then AGB101 220 mg
Placebo, given as a capsule, once daily for 2 weeks. After a 4 week washout, to be followed by AGB101 220 mg/day capsule, once daily dosing for 2 weeks.
AGB101 220 mg: AGB101 oral dose of 220 mg/day capsule, given as once-daily dosing.
Placebo: Placebo, oral capsule given once-daily.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
Baseline characteristics by cohort
| Measure |
AGB101 220 mg, Then Placebo
n=13 Participants
AGB101 220 mg/day capsule, once daily dosing for 2 weeks. After a 4 week washout, to be followed by Placebo, given as a capsule, once daily dosing for 2 weeks.
AGB101 220 mg: AGB101 oral dose of 220 mg/day capsule, given as once-daily dosing.
Placebo: Placebo, oral capsule given once-daily.
|
Placebo, Then AGB101 220 mg
n=12 Participants
Placebo, given as a capsule, once daily for 2 weeks. After a 4 week washout, to be followed by AGB101 220 mg/day capsule, once daily dosing for 2 weeks.
AGB101 220 mg: AGB101 oral dose of 220 mg/day capsule, given as once-daily dosing.
Placebo: Placebo, oral capsule given once-daily.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
0 Participants
n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
0 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
4 Participants
n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
9 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
8 Participants
n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
16 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 4 • n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
67 years
STANDARD_DEVIATION 5 • n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
66.2 years
STANDARD_DEVIATION 4.5 • n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
6 Participants
n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
15 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
6 Participants
n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
10 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
0 Participants
n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
0 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
12 Participants
n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
25 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
0 Participants
n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
0 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
0 Participants
n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
0 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
0 Participants
n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
0 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
0 Participants
n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
0 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
0 Participants
n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
0 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
12 Participants
n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
25 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
0 Participants
n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
0 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
0 Participants
n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
0 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
12 participants
n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
26 participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
|
Apolipoprotein E (APOE) Status
APOE e4 Carrier
|
3 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
2 Participants
n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
5 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
|
Apolipoprotein E (APOE) Status
APOE e4 Non-Carrier
|
10 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
10 Participants
n=7 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
20 Participants
n=5 Participants • One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
|
PRIMARY outcome
Timeframe: 2 weeks after treatment between AGB101 and PlaceboPopulation: A total of 25 subjects who were treated with AGB 101 and Placebo (order-balanced), then conducted a paired t-test to detect the treatment effect vs placebo.
The seed-based functional connectivity strengths of the hippocampus network and the default mode network will be employed to measure the changes between AGB101 and Placebo perturbation. The functional connectivity strengths will be measured with the median of the Pearson cross-correlation coefficients over entire brain regions.
Outcome measures
| Measure |
AGB101 220 mg
n=25 Participants
AGB101 220 mg/day capsule, once daily dosing for 2 weeks.
AGB101 220 mg: AGB101 oral dose of 220 mg/day capsule, given as once-daily dosing.
|
Placebo
n=25 Participants
Placebo, given as a capsule, once daily for 2 weeks.
Placebo: Placebo, oral capsule given once-daily.
|
|---|---|---|
|
Functional Connectivity Strengths of Neural Networks
|
0.233 Pearson coefficient
Standard Deviation 0.132
|
0.318 Pearson coefficient
Standard Deviation 0.127
|
SECONDARY outcome
Timeframe: Placebo vs AGB101 2 weeks after treatment paired t-testPopulation: Measure RAVLT Delayed recall standard score memory test
Rey Auditory Verbal Learning Test (AVLT), delayed recall Scaled integer will be employed to measure the episodic memory changes before and after AGB101 treatment. The AVLT score will be recorded as a standard score. The theoretical range: min 50, max 155, the higher the better. The higher the number is, the better the memory. It is an integer number.
Outcome measures
| Measure |
AGB101 220 mg
n=25 Participants
AGB101 220 mg/day capsule, once daily dosing for 2 weeks.
AGB101 220 mg: AGB101 oral dose of 220 mg/day capsule, given as once-daily dosing.
|
Placebo
n=25 Participants
Placebo, given as a capsule, once daily for 2 weeks.
Placebo: Placebo, oral capsule given once-daily.
|
|---|---|---|
|
Rey Auditory Verbal Learning Test (AVLT), Delayed Recall Scaled Integer. The Higher is the Better
|
108 score on a scale
Standard Deviation 17
|
105 score on a scale
Standard Deviation 16
|
Adverse Events
AGB101 220 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AGB101 220 mg
n=26 participants at risk
AEs judged related to intervention while on AGB101 220 mg
|
Placebo
n=26 participants at risk
AEs judged related to intervention while on Placebo
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
7.7%
2/26 • Number of events 2 • From Baseline Visit Through 4 Week Follow Up Call (an average of 12 weeks)
|
3.8%
1/26 • Number of events 1 • From Baseline Visit Through 4 Week Follow Up Call (an average of 12 weeks)
|
|
General disorders
Sleepiness
|
3.8%
1/26 • Number of events 1 • From Baseline Visit Through 4 Week Follow Up Call (an average of 12 weeks)
|
0.00%
0/26 • From Baseline Visit Through 4 Week Follow Up Call (an average of 12 weeks)
|
|
Nervous system disorders
Brain Zaps
|
0.00%
0/26 • From Baseline Visit Through 4 Week Follow Up Call (an average of 12 weeks)
|
3.8%
1/26 • Number of events 1 • From Baseline Visit Through 4 Week Follow Up Call (an average of 12 weeks)
|
|
Nervous system disorders
Visual Aura
|
0.00%
0/26 • From Baseline Visit Through 4 Week Follow Up Call (an average of 12 weeks)
|
3.8%
1/26 • Number of events 1 • From Baseline Visit Through 4 Week Follow Up Call (an average of 12 weeks)
|
|
Infections and infestations
Cold Symptoms
|
3.8%
1/26 • Number of events 1 • From Baseline Visit Through 4 Week Follow Up Call (an average of 12 weeks)
|
0.00%
0/26 • From Baseline Visit Through 4 Week Follow Up Call (an average of 12 weeks)
|
|
Nervous system disorders
Feeling Jittery
|
3.8%
1/26 • Number of events 1 • From Baseline Visit Through 4 Week Follow Up Call (an average of 12 weeks)
|
0.00%
0/26 • From Baseline Visit Through 4 Week Follow Up Call (an average of 12 weeks)
|
|
Psychiatric disorders
Depressed Mood
|
3.8%
1/26 • Number of events 1 • From Baseline Visit Through 4 Week Follow Up Call (an average of 12 weeks)
|
0.00%
0/26 • From Baseline Visit Through 4 Week Follow Up Call (an average of 12 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between Dr. Li and AgeneBio since AgeneBio supplies AGB101 drug to Dr. Li's for conducting the trial. The only restriction on the PI is that the sponsor can review results communications prior to public release.
- Publication restrictions are in place
Restriction type: OTHER