Trial Outcomes & Findings for Study of AMDX-2011P as a Retinal Tracer in Subjects With Neurodegenerative Diseases Associated With Amyloidogenic Proteinopathy (NCT NCT05542576)
NCT ID: NCT05542576
Last Updated: 2025-08-20
Results Overview
Incidence of Treatment Emergent Adverse Events (TEAEs) at for each cohort (dose level).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
13 participants
Primary outcome timeframe
1 week
Results posted on
2025-08-20
Participant Flow
13 subjects: 3 in Cohort 1 (25mg dose) 4 in Cohort 2 (50mg dose) 6 in Cohort 3 (100mg dose)
Participant milestones
| Measure |
AMDX2011P 25mg
AMDX2011P 25mg (1ml) single bolus injection intravenous for diagnostic review
|
AMDX2011P 50mg
AMDX2011P 50mg (2ml) single bolus injection intravenous for diagnostic review
|
AMDX2011P 100mg
AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
6
|
|
Overall Study
COMPLETED
|
3
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of AMDX-2011P as a Retinal Tracer in Subjects With Neurodegenerative Diseases Associated With Amyloidogenic Proteinopathy
Baseline characteristics by cohort
| Measure |
AMDX2011P 25mg
n=3 Participants
25mg (1ml) single bolus injection intravenous for diagnostic review
|
AMDX2011P 50mg
n=4 Participants
AMDX2011P 50mg (2ml) single bolus injection intravenous for diagnostic review
|
AMDX2011P 100mg
n=6 Participants
AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 weekIncidence of Treatment Emergent Adverse Events (TEAEs) at for each cohort (dose level).
Outcome measures
| Measure |
AMDX2011P 25mg
n=3 Participants
25mg (1ml) single bolus injection intravenous for diagnostic review
|
AMDX2011P 50mg
n=4 Participants
AMDX2011P 50mg (2ml) single bolus injection intravenous for diagnostic review
|
AMDX2011P 100mg
n=6 Participants
AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review
|
|---|---|---|---|
|
AMDX-2011P Adverse Events Profile
|
0 Treatment Emergent Adverse Events TEAEs
|
1 Treatment Emergent Adverse Events TEAEs
|
3 Treatment Emergent Adverse Events TEAEs
|
SECONDARY outcome
Timeframe: 8 hoursPeak Plasma Concentration (Cmax)
Outcome measures
| Measure |
AMDX2011P 25mg
n=3 Participants
25mg (1ml) single bolus injection intravenous for diagnostic review
|
AMDX2011P 50mg
n=3 Participants
AMDX2011P 50mg (2ml) single bolus injection intravenous for diagnostic review
|
AMDX2011P 100mg
n=6 Participants
AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review
|
|---|---|---|---|
|
Concentration of AMDX-2011P
|
4400 ng/mL
Standard Deviation 572
|
16600 ng/mL
Standard Deviation 15800
|
14600 ng/mL
Standard Deviation 3890
|
SECONDARY outcome
Timeframe: 8 hoursArea under the plasma concentration versus time curve (AUC)
Outcome measures
| Measure |
AMDX2011P 25mg
n=3 Participants
25mg (1ml) single bolus injection intravenous for diagnostic review
|
AMDX2011P 50mg
n=3 Participants
AMDX2011P 50mg (2ml) single bolus injection intravenous for diagnostic review
|
AMDX2011P 100mg
n=6 Participants
AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review
|
|---|---|---|---|
|
Pharmacokinetic Analysis of AMDX-2011P
|
706 h*ng/mL
Standard Deviation 110
|
3170 h*ng/mL
Standard Deviation 3290
|
2330 h*ng/mL
Standard Deviation 637
|
Adverse Events
AMDX2011P 25mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AMDX2011P 50mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AMDX2011P 100mg
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 |
AMDX2011P 25mg
n=3 participants at risk
25mg (1ml) single bolus injection intravenous for diagnostic review
|
AMDX2011P 50mg
n=4 participants at risk
AMDX2011P 50mg (2ml) single bolus injection intravenous for diagnostic review
|
AMDX2011P 100mg
n=6 participants at risk
AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review
|
|---|---|---|---|
|
Nervous system disorders
Altered taste
|
0.00%
0/3 • From enrollment until end of follow-up, up to 8 days
|
25.0%
1/4 • From enrollment until end of follow-up, up to 8 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 8 days
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • From enrollment until end of follow-up, up to 8 days
|
0.00%
0/4 • From enrollment until end of follow-up, up to 8 days
|
33.3%
2/6 • From enrollment until end of follow-up, up to 8 days
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From enrollment until end of follow-up, up to 8 days
|
25.0%
1/4 • From enrollment until end of follow-up, up to 8 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 8 days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From enrollment until end of follow-up, up to 8 days
|
25.0%
1/4 • From enrollment until end of follow-up, up to 8 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 8 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From enrollment until end of follow-up, up to 8 days
|
0.00%
0/4 • From enrollment until end of follow-up, up to 8 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 8 days
|
|
General disorders
Feeling Hot
|
0.00%
0/3 • From enrollment until end of follow-up, up to 8 days
|
0.00%
0/4 • From enrollment until end of follow-up, up to 8 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 8 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place