Trial Outcomes & Findings for A Longitudinal Evaluation of a Radiotracer for Use in Tau Tracking (NCT NCT03919669)
NCT ID: NCT03919669
Last Updated: 2023-08-03
Results Overview
Composite mean SUVR across standard regions including: numerator was the entorhinal, amygdala, fusiform, inferior temporal, middle temporal cortex; denominator was the inferior cerebellum cortex. The SUVR is a ratio and has a theoretic interpretable minimum of 1.0. This primary outcome is reported by the three primary groups: Healthy Volunteers, Mild Cognitive Impairment, and Dementia.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Baseline to 12 months
Results posted on
2023-08-03
Participant Flow
Participant milestones
| Measure |
Healthy Volunteers
As described in the study eligibility criteria:
* Normal Cognition based on cognitive results at screening.
* Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the Baseline \[18F\]MK-6240 imaging visit.
* CDR global score =0
|
Mild Cognitive Impairment
As described in the study eligibility criteria:
* Have screening \[11C\]PiB PET imaging demonstrating amyloid binding based on qualitative read or DVR index value \>1.20.
* MMSE score 26-30 (inclusive), CDR global score 0.5 for subjects with MCI
* MMSE score 22-26 (inclusive), CDR global score 0.5 or 1 for subjects with mild dementia due to AD
* MMSE score 16-21 (inclusive), CDR global score 1-2 for subjects with moderate dementia due to AD
* A structural brain MRI with no evidence of non-AD disease to account for dementia or MRI exclusion criteria.
|
Dementia
As described in the study eligibility criteria:
* Have screening \[11C\]PiB PET imaging demonstrating amyloid binding based on qualitative read or DVR index value \>1.20.
* MMSE score 26-30 (inclusive), CDR global score 0.5 for subjects with MCI
* MMSE score 22-26 (inclusive), CDR global score 0.5 or 1 for subjects with mild dementia due to AD
* MMSE score 16-21 (inclusive), CDR global score 1-2 for subjects with moderate dementia due to AD
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
13
|
|
Overall Study
COMPLETED
|
5
|
8
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Healthy Volunteers
As described in the study eligibility criteria:
* Normal Cognition based on cognitive results at screening.
* Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the Baseline \[18F\]MK-6240 imaging visit.
* CDR global score =0
|
Mild Cognitive Impairment
As described in the study eligibility criteria:
* Have screening \[11C\]PiB PET imaging demonstrating amyloid binding based on qualitative read or DVR index value \>1.20.
* MMSE score 26-30 (inclusive), CDR global score 0.5 for subjects with MCI
* MMSE score 22-26 (inclusive), CDR global score 0.5 or 1 for subjects with mild dementia due to AD
* MMSE score 16-21 (inclusive), CDR global score 1-2 for subjects with moderate dementia due to AD
* A structural brain MRI with no evidence of non-AD disease to account for dementia or MRI exclusion criteria.
|
Dementia
As described in the study eligibility criteria:
* Have screening \[11C\]PiB PET imaging demonstrating amyloid binding based on qualitative read or DVR index value \>1.20.
* MMSE score 26-30 (inclusive), CDR global score 0.5 for subjects with MCI
* MMSE score 22-26 (inclusive), CDR global score 0.5 or 1 for subjects with mild dementia due to AD
* MMSE score 16-21 (inclusive), CDR global score 1-2 for subjects with moderate dementia due to AD
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
A Longitudinal Evaluation of a Radiotracer for Use in Tau Tracking
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=6 Participants
As described in the study eligibility criteria:
* Normal Cognition based on cognitive results at screening.
* Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the Baseline \[18F\]MK-6240 imaging visit.
* CDR global score =0
|
Mild Cognitive Impairment
n=8 Participants
As described in the study eligibility criteria:
* Have screening \[11C\]PiB PET imaging demonstrating amyloid binding based on qualitative read or DVR index value \>1.20.
* MMSE score 26-30 (inclusive), CDR global score 0.5 for subjects with MCI
* MMSE score 22-26 (inclusive), CDR global score 0.5 or 1 for subjects with mild dementia due to AD
* MMSE score 16-21 (inclusive), CDR global score 1-2 for subjects with moderate dementia due to AD
* A structural brain MRI with no evidence of non-AD disease to account for dementia or MRI exclusion criteria.
|
Dementia
n=13 Participants
As described in the study eligibility criteria:
* Have screening \[11C\]PiB PET imaging demonstrating amyloid binding based on qualitative read or DVR index value \>1.20.
* MMSE score 26-30 (inclusive), CDR global score 0.5 for subjects with MCI
* MMSE score 22-26 (inclusive), CDR global score 0.5 or 1 for subjects with mild dementia due to AD
* MMSE score 16-21 (inclusive), CDR global score 1-2 for subjects with moderate dementia due to AD
|
Total
n=27 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
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Age, Continuous
|
69.85 years
n=5 Participants
|
71.60 years
n=7 Participants
|
74.52 years
n=5 Participants
|
72.62 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
27 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
|
|
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
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
27 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
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
13 participants
n=5 Participants
|
27 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsPopulation: 26 of the 27 participants completed the 12 month interval
Composite mean SUVR across standard regions including: numerator was the entorhinal, amygdala, fusiform, inferior temporal, middle temporal cortex; denominator was the inferior cerebellum cortex. The SUVR is a ratio and has a theoretic interpretable minimum of 1.0. This primary outcome is reported by the three primary groups: Healthy Volunteers, Mild Cognitive Impairment, and Dementia.
Outcome measures
| Measure |
Healthy Volunteers
n=6 Participants
As described in the study eligibility criteria:
* Normal Cognition based on cognitive results at screening.
* Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the Baseline \[18F\]MK-6240 imaging visit.
* CDR global score =0
|
Mild Cognitive Impairment
n=8 Participants
As described in the study eligibility criteria:
* Have screening \[11C\]PiB PET imaging demonstrating amyloid binding based on qualitative read or DVR index value \>1.20.
* MMSE score 26-30 (inclusive), CDR global score 0.5 for subjects with MCI
* MMSE score 22-26 (inclusive), CDR global score 0.5 or 1 for subjects with mild dementia due to AD
* MMSE score 16-21 (inclusive), CDR global score 1-2 for subjects with moderate dementia due to AD
* A structural brain MRI with no evidence of non-AD disease to account for dementia or MRI exclusion criteria.
|
Dementia
n=13 Participants
As described in the study eligibility criteria:
* Have screening \[11C\]PiB PET imaging demonstrating amyloid binding based on qualitative read or DVR index value \>1.20.
* MMSE score 26-30 (inclusive), CDR global score 0.5 for subjects with MCI
* MMSE score 22-26 (inclusive), CDR global score 0.5 or 1 for subjects with mild dementia due to AD
* MMSE score 16-21 (inclusive), CDR global score 1-2 for subjects with moderate dementia due to AD
|
|---|---|---|---|
|
Change in [18F]MK-6240 Standard Uptake Value Ratio (SUVR) Uptake
|
0.00 SUVR
Standard Deviation 0.05
|
0.10 SUVR
Standard Deviation 0.07
|
0.12 SUVR
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: 26 of the 27 participants completed the 12 month interval
This outcome is correlational and therefore the arms/groups are collapsed to All Subjects so that we can assess the overall pattern of relationship between cognition and tau signal across the entire continuum of Alzheimer's disease. The ADAS-cog is one of the most frequently used tests to measure cognition in clinical trials in AD. The first 11 items of the ADAS-cog were used for this outcome. The ADAS was developed as a two-part scale: one that measured cognitive functions and one that measured non-cognitive functions such as mood and behavior. Most current research, including this study, uses the ADAS-Cog, which is the sub-scale that measures cognitive ability. The ADAS-cog score is based on incorrect items or errors and has a range of 0-50, where lower scores indicate better cognitive functioning.
Outcome measures
| Measure |
Healthy Volunteers
n=27 Participants
As described in the study eligibility criteria:
* Normal Cognition based on cognitive results at screening.
* Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the Baseline \[18F\]MK-6240 imaging visit.
* CDR global score =0
|
Mild Cognitive Impairment
As described in the study eligibility criteria:
* Have screening \[11C\]PiB PET imaging demonstrating amyloid binding based on qualitative read or DVR index value \>1.20.
* MMSE score 26-30 (inclusive), CDR global score 0.5 for subjects with MCI
* MMSE score 22-26 (inclusive), CDR global score 0.5 or 1 for subjects with mild dementia due to AD
* MMSE score 16-21 (inclusive), CDR global score 1-2 for subjects with moderate dementia due to AD
* A structural brain MRI with no evidence of non-AD disease to account for dementia or MRI exclusion criteria.
|
Dementia
As described in the study eligibility criteria:
* Have screening \[11C\]PiB PET imaging demonstrating amyloid binding based on qualitative read or DVR index value \>1.20.
* MMSE score 26-30 (inclusive), CDR global score 0.5 for subjects with MCI
* MMSE score 22-26 (inclusive), CDR global score 0.5 or 1 for subjects with mild dementia due to AD
* MMSE score 16-21 (inclusive), CDR global score 1-2 for subjects with moderate dementia due to AD
|
|---|---|---|---|
|
The Correlation Between the Change in [18F]MK-6240 Uptake and the Change in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) Using Items 1-11
|
.02 Spearman Rho
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: 26 of the 27 participants completed the 12 month interval
This outcome is correlational and therefore the arms/groups are collapsed to All Subjects so that we can assess the overall pattern of relationship between cognition and tau signal across the entire continuum of Alzheimer's disease. The CDR was developed primarily for use in persons with dementia of the Alzheimer type. The six domains of CDR are: Memory, Orientation, Judgment and Problem-solving, Community Affairs, Home and Hobbies, and Personal Care. Each domain is rated on a 5-point scale of functioning: 0 no impairment; 0.5 questionable impairment; 1 mild impairment; 2 moderate impairment; and 3 severe impairment. The Sum of Boxes is the score used which is simply the sum of the 6 Domain Box Scores. The range is 0-18 with lower scores indicating better cognitive function.
Outcome measures
| Measure |
Healthy Volunteers
n=27 Participants
As described in the study eligibility criteria:
* Normal Cognition based on cognitive results at screening.
* Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the Baseline \[18F\]MK-6240 imaging visit.
* CDR global score =0
|
Mild Cognitive Impairment
As described in the study eligibility criteria:
* Have screening \[11C\]PiB PET imaging demonstrating amyloid binding based on qualitative read or DVR index value \>1.20.
* MMSE score 26-30 (inclusive), CDR global score 0.5 for subjects with MCI
* MMSE score 22-26 (inclusive), CDR global score 0.5 or 1 for subjects with mild dementia due to AD
* MMSE score 16-21 (inclusive), CDR global score 1-2 for subjects with moderate dementia due to AD
* A structural brain MRI with no evidence of non-AD disease to account for dementia or MRI exclusion criteria.
|
Dementia
As described in the study eligibility criteria:
* Have screening \[11C\]PiB PET imaging demonstrating amyloid binding based on qualitative read or DVR index value \>1.20.
* MMSE score 26-30 (inclusive), CDR global score 0.5 for subjects with MCI
* MMSE score 22-26 (inclusive), CDR global score 0.5 or 1 for subjects with mild dementia due to AD
* MMSE score 16-21 (inclusive), CDR global score 1-2 for subjects with moderate dementia due to AD
|
|---|---|---|---|
|
Correlate the Changes in [18F]MK-6240 Uptake and Changes in Clinical Cognitive Assessments by Clinical Dementia Rating Scale (CDR).
|
.23 Spearman Rho
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: 26 of the 27 participants completed the 12 month interval
This outcome is correlational and therefore the arms/groups are collapsed to All Subjects so that we can assess the overall pattern of relationship between cognition and tau signal across the entire continuum of Alzheimer's disease. The MMSE is a sensitive, valid and reliable 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used as screening tool for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus, making it an effective way to document an individual's response to treatment. The range is 0-30 with higher scores indicating better cognitive functioning.
Outcome measures
| Measure |
Healthy Volunteers
n=27 Participants
As described in the study eligibility criteria:
* Normal Cognition based on cognitive results at screening.
* Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the Baseline \[18F\]MK-6240 imaging visit.
* CDR global score =0
|
Mild Cognitive Impairment
As described in the study eligibility criteria:
* Have screening \[11C\]PiB PET imaging demonstrating amyloid binding based on qualitative read or DVR index value \>1.20.
* MMSE score 26-30 (inclusive), CDR global score 0.5 for subjects with MCI
* MMSE score 22-26 (inclusive), CDR global score 0.5 or 1 for subjects with mild dementia due to AD
* MMSE score 16-21 (inclusive), CDR global score 1-2 for subjects with moderate dementia due to AD
* A structural brain MRI with no evidence of non-AD disease to account for dementia or MRI exclusion criteria.
|
Dementia
As described in the study eligibility criteria:
* Have screening \[11C\]PiB PET imaging demonstrating amyloid binding based on qualitative read or DVR index value \>1.20.
* MMSE score 26-30 (inclusive), CDR global score 0.5 for subjects with MCI
* MMSE score 22-26 (inclusive), CDR global score 0.5 or 1 for subjects with mild dementia due to AD
* MMSE score 16-21 (inclusive), CDR global score 1-2 for subjects with moderate dementia due to AD
|
|---|---|---|---|
|
Correlate the Changes in [18F]MK-6240 Uptake and Changes in Clinical Cognitive Assessments by Mini-Mental Status Exam (MMSE)
|
.43 Spearman Rho
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 24 monthsPopulation: 26 of the 27 participants completed the 24 month interval
Composite mean SUVR across standard regions including: numerator was the entorhinal, amygdala, fusiform, inferior temporal, middle temporal cortex; denominator was the inferior cerebellum cortex. The SUVR is a ratio and has a theoretic interpretable minimum of 1.0. This primary outcome is reported by the three primary groups: Healthy Volunteers, Mild Cognitive Impairment, and Dementia.
Outcome measures
| Measure |
Healthy Volunteers
n=6 Participants
As described in the study eligibility criteria:
* Normal Cognition based on cognitive results at screening.
* Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the Baseline \[18F\]MK-6240 imaging visit.
* CDR global score =0
|
Mild Cognitive Impairment
n=8 Participants
As described in the study eligibility criteria:
* Have screening \[11C\]PiB PET imaging demonstrating amyloid binding based on qualitative read or DVR index value \>1.20.
* MMSE score 26-30 (inclusive), CDR global score 0.5 for subjects with MCI
* MMSE score 22-26 (inclusive), CDR global score 0.5 or 1 for subjects with mild dementia due to AD
* MMSE score 16-21 (inclusive), CDR global score 1-2 for subjects with moderate dementia due to AD
* A structural brain MRI with no evidence of non-AD disease to account for dementia or MRI exclusion criteria.
|
Dementia
n=13 Participants
As described in the study eligibility criteria:
* Have screening \[11C\]PiB PET imaging demonstrating amyloid binding based on qualitative read or DVR index value \>1.20.
* MMSE score 26-30 (inclusive), CDR global score 0.5 for subjects with MCI
* MMSE score 22-26 (inclusive), CDR global score 0.5 or 1 for subjects with mild dementia due to AD
* MMSE score 16-21 (inclusive), CDR global score 1-2 for subjects with moderate dementia due to AD
|
|---|---|---|---|
|
Change in [18F]MK-6240 Standard Uptake Value Ratio (SUVR) Uptake
|
-.01 SUVR
Standard Deviation .09
|
.21 SUVR
Standard Deviation .16
|
.24 SUVR
Standard Deviation .34
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: 26 of the 27 participants completed the 6 month interval
Composite mean SUVR across standard regions including: numerator was the entorhinal, amygdala, fusiform, inferior temporal, middle temporal cortex; denominator was the inferior cerebellum cortex. The SUVR is a ratio and has a theoretic interpretable minimum of 1.0. This primary outcome is reported by the three primary groups: Healthy Volunteers, Mild Cognitive Impairment, and Dementia.
Outcome measures
| Measure |
Healthy Volunteers
n=6 Participants
As described in the study eligibility criteria:
* Normal Cognition based on cognitive results at screening.
* Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the Baseline \[18F\]MK-6240 imaging visit.
* CDR global score =0
|
Mild Cognitive Impairment
n=8 Participants
As described in the study eligibility criteria:
* Have screening \[11C\]PiB PET imaging demonstrating amyloid binding based on qualitative read or DVR index value \>1.20.
* MMSE score 26-30 (inclusive), CDR global score 0.5 for subjects with MCI
* MMSE score 22-26 (inclusive), CDR global score 0.5 or 1 for subjects with mild dementia due to AD
* MMSE score 16-21 (inclusive), CDR global score 1-2 for subjects with moderate dementia due to AD
* A structural brain MRI with no evidence of non-AD disease to account for dementia or MRI exclusion criteria.
|
Dementia
n=13 Participants
As described in the study eligibility criteria:
* Have screening \[11C\]PiB PET imaging demonstrating amyloid binding based on qualitative read or DVR index value \>1.20.
* MMSE score 26-30 (inclusive), CDR global score 0.5 for subjects with MCI
* MMSE score 22-26 (inclusive), CDR global score 0.5 or 1 for subjects with mild dementia due to AD
* MMSE score 16-21 (inclusive), CDR global score 1-2 for subjects with moderate dementia due to AD
|
|---|---|---|---|
|
Change in [18F]MK-6240 Standard Uptake Value Ratio (SUVR) Uptake
|
-.03 SUVR
Standard Deviation .04
|
-.07 SUVR
Standard Deviation .26
|
.19 SUVR
Standard Deviation .33
|
Adverse Events
Dementia
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Healthy Volunteer
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Mild Cognitive Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dementia
n=13 participants at risk
All subjects will complete PET imaging sessions evaluating the tau PET radioligand \[18F\]MK-6240 at baseline, as well as at 6, 12 and 24 months post-baseline.
If unable to complete the 6 month, 12 month, or 24 month visit, an 18 month and/or 30 month visit may instead be scheduled, totaling a maximum of four time points.
All Subjects: All subjects will be given the experimental tau PET radioligand \[18F\]MK-6240
|
Healthy Volunteer
n=6 participants at risk
All subjects will complete PET imaging sessions evaluating the tau PET radioligand \[18F\]MK-6240 at baseline, as well as at 6, 12 and 24 months post-baseline.
If unable to complete the 6 month, 12 month, or 24 month visit, an 18 month and/or 30 month visit may instead be scheduled, totaling a maximum of four time points.
All Subjects: All subjects will be given the experimental tau PET radioligand \[18F\]MK-6240
|
Mild Cognitive Impairment
n=8 participants at risk
All subjects will complete PET imaging sessions evaluating the tau PET radioligand \[18F\]MK-6240 at baseline, as well as at 6, 12 and 24 months post-baseline.
If unable to complete the 6 month, 12 month, or 24 month visit, an 18 month and/or 30 month visit may instead be scheduled, totaling a maximum of four time points.
All Subjects: All subjects will be given the experimental tau PET radioligand \[18F\]MK-6240
|
|---|---|---|---|
|
General disorders
Injection Site Reaction
|
7.7%
1/13 • Number of events 1 • Given that this longitudinal study involves procedures that will occur at 6-12 month intervals and does not include chronic treatment with an investigational agent, adverse events (AEs) and serious adverse events (SAEs) were captured during the study visit before and after PiB and MK6240 scans, within 24 hours after the scan. Adverse events were monitored from signing the informed consent form through study completion, on average 2.5 years.
The subjects received a phone call within 4 days from the study team for the purpose of ascertaining their wellbeing and information on adverse events that occur within 24 hours after the scan. If any adverse events were discovered, a clinician continued to follow up with the subject until resolved.
|
16.7%
1/6 • Number of events 1 • Given that this longitudinal study involves procedures that will occur at 6-12 month intervals and does not include chronic treatment with an investigational agent, adverse events (AEs) and serious adverse events (SAEs) were captured during the study visit before and after PiB and MK6240 scans, within 24 hours after the scan. Adverse events were monitored from signing the informed consent form through study completion, on average 2.5 years.
The subjects received a phone call within 4 days from the study team for the purpose of ascertaining their wellbeing and information on adverse events that occur within 24 hours after the scan. If any adverse events were discovered, a clinician continued to follow up with the subject until resolved.
|
0.00%
0/8 • Given that this longitudinal study involves procedures that will occur at 6-12 month intervals and does not include chronic treatment with an investigational agent, adverse events (AEs) and serious adverse events (SAEs) were captured during the study visit before and after PiB and MK6240 scans, within 24 hours after the scan. Adverse events were monitored from signing the informed consent form through study completion, on average 2.5 years.
The subjects received a phone call within 4 days from the study team for the purpose of ascertaining their wellbeing and information on adverse events that occur within 24 hours after the scan. If any adverse events were discovered, a clinician continued to follow up with the subject until resolved.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.7%
1/13 • Number of events 1 • Given that this longitudinal study involves procedures that will occur at 6-12 month intervals and does not include chronic treatment with an investigational agent, adverse events (AEs) and serious adverse events (SAEs) were captured during the study visit before and after PiB and MK6240 scans, within 24 hours after the scan. Adverse events were monitored from signing the informed consent form through study completion, on average 2.5 years.
The subjects received a phone call within 4 days from the study team for the purpose of ascertaining their wellbeing and information on adverse events that occur within 24 hours after the scan. If any adverse events were discovered, a clinician continued to follow up with the subject until resolved.
|
0.00%
0/6 • Given that this longitudinal study involves procedures that will occur at 6-12 month intervals and does not include chronic treatment with an investigational agent, adverse events (AEs) and serious adverse events (SAEs) were captured during the study visit before and after PiB and MK6240 scans, within 24 hours after the scan. Adverse events were monitored from signing the informed consent form through study completion, on average 2.5 years.
The subjects received a phone call within 4 days from the study team for the purpose of ascertaining their wellbeing and information on adverse events that occur within 24 hours after the scan. If any adverse events were discovered, a clinician continued to follow up with the subject until resolved.
|
0.00%
0/8 • Given that this longitudinal study involves procedures that will occur at 6-12 month intervals and does not include chronic treatment with an investigational agent, adverse events (AEs) and serious adverse events (SAEs) were captured during the study visit before and after PiB and MK6240 scans, within 24 hours after the scan. Adverse events were monitored from signing the informed consent form through study completion, on average 2.5 years.
The subjects received a phone call within 4 days from the study team for the purpose of ascertaining their wellbeing and information on adverse events that occur within 24 hours after the scan. If any adverse events were discovered, a clinician continued to follow up with the subject until resolved.
|
|
General disorders
Infusion Site Extravasation
|
7.7%
1/13 • Number of events 1 • Given that this longitudinal study involves procedures that will occur at 6-12 month intervals and does not include chronic treatment with an investigational agent, adverse events (AEs) and serious adverse events (SAEs) were captured during the study visit before and after PiB and MK6240 scans, within 24 hours after the scan. Adverse events were monitored from signing the informed consent form through study completion, on average 2.5 years.
The subjects received a phone call within 4 days from the study team for the purpose of ascertaining their wellbeing and information on adverse events that occur within 24 hours after the scan. If any adverse events were discovered, a clinician continued to follow up with the subject until resolved.
|
0.00%
0/6 • Given that this longitudinal study involves procedures that will occur at 6-12 month intervals and does not include chronic treatment with an investigational agent, adverse events (AEs) and serious adverse events (SAEs) were captured during the study visit before and after PiB and MK6240 scans, within 24 hours after the scan. Adverse events were monitored from signing the informed consent form through study completion, on average 2.5 years.
The subjects received a phone call within 4 days from the study team for the purpose of ascertaining their wellbeing and information on adverse events that occur within 24 hours after the scan. If any adverse events were discovered, a clinician continued to follow up with the subject until resolved.
|
0.00%
0/8 • Given that this longitudinal study involves procedures that will occur at 6-12 month intervals and does not include chronic treatment with an investigational agent, adverse events (AEs) and serious adverse events (SAEs) were captured during the study visit before and after PiB and MK6240 scans, within 24 hours after the scan. Adverse events were monitored from signing the informed consent form through study completion, on average 2.5 years.
The subjects received a phone call within 4 days from the study team for the purpose of ascertaining their wellbeing and information on adverse events that occur within 24 hours after the scan. If any adverse events were discovered, a clinician continued to follow up with the subject until resolved.
|
Additional Information
Dr. Sterling Johnson
University of WI Alzheimer's Disease Research Center
Phone: 608-262-9549
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place