We are currently in month 6 of the study.
This report is meant to provide a quick overview of the OPTIMUM-Neuro study, to facilitate discussion on its bi-weekly conference calls. All data summarized here derives from the ‘tracking’ arm of the WashU REDCap database (arm 6), and thus is only as accurate as the data captured there.
Recruitment
|
|
CU
|
LA
|
UP
|
UT
|
WU
|
|
|
metric
|
n
|
%
|
n
|
%
|
n
|
%
|
n
|
%
|
n
|
%
|
total
|
|
Consent1
|
|
consented current month
|
1
|
25%
|
1
|
25%
|
2
|
50%
|
4
|
100%
|
2
|
50%
|
10
|
|
consented to date
|
30
|
136%
|
20
|
91%
|
23
|
105%
|
16
|
73%
|
19
|
86%
|
108
|
|
Enrollment2
|
|
enrolled current month
|
1
|
25%
|
0
|
0%
|
2
|
50%
|
2
|
50%
|
3
|
75%
|
8
|
|
enrolled to date
|
3
|
14%
|
3
|
14%
|
15
|
68%
|
0
|
0%
|
13
|
59%
|
34
|
|
Completion3
|
|
completed current month
|
0
|
–
|
0
|
–
|
0
|
–
|
0
|
–
|
0
|
–
|
0
|
|
completed to date
|
0
|
–
|
0
|
–
|
0
|
–
|
0
|
–
|
0
|
–
|
0
|
|
Termination4
|
|
terminated during baseline
|
0
|
–
|
0
|
–
|
0
|
–
|
0
|
–
|
0
|
–
|
0
|
|
terminated during 6 mth FU
|
0
|
–
|
0
|
–
|
0
|
–
|
0
|
–
|
0
|
–
|
0
|
|
terminated during 24 mth FU
|
0
|
–
|
0
|
–
|
0
|
–
|
0
|
–
|
0
|
–
|
0
|
1 Consent counts all participants who signed an OPTIMUM-Neuro consent form.
|
2 Enrollment counts all participants who completed ≥2/3 of the MRI, bloodwork, and neuropsych at the baseline visit.
|
3 Completion counts all enrolled participants who completed the 24 mth FU visit.
|
4 Termination counts participants coded as: ‘not eligible for randomization’, ‘withdrew’, ‘lost to follow-up’, ‘death’, ‘investigator discretion’, and ‘other’. Termination does not capture participants who completed the study, i.e., this category is independent from Completion.
|
|
Note:
|
Current month captures calendar month. The % columns calculate percentage of target, with all sites having common targets.
|
Enrollment breakdown
|
|
CU
|
LA
|
UP
|
UT
|
WU
|
|
|
metric
|
n
|
%
|
n
|
%
|
n
|
%
|
n
|
%
|
n
|
%
|
total
|
|
Neuropsych1
|
|
completed neuropsych current month
|
1
|
25%
|
0
|
0%
|
2
|
50%
|
3
|
75%
|
3
|
75%
|
9
|
|
completed neuropsych to date
|
29
|
132%
|
12
|
55%
|
23
|
105%
|
3
|
14%
|
19
|
86%
|
86
|
|
Blood2
|
|
completed blood current month
|
0
|
0%
|
0
|
0%
|
2
|
50%
|
2
|
50%
|
2
|
50%
|
6
|
|
completed blood to date
|
5
|
23%
|
13
|
59%
|
23
|
105%
|
14
|
64%
|
17
|
77%
|
72
|
|
MRI3
|
|
completed MRI current month
|
1
|
25%
|
0
|
0%
|
1
|
25%
|
4
|
100%
|
3
|
75%
|
9
|
|
completed MRI to date
|
18
|
82%
|
4
|
18%
|
15
|
68%
|
8
|
36%
|
15
|
68%
|
60
|
1 Neuropsych counts all participants who completed both the RBANS and D-KEFS in full.
|
2 Blood counts all participants who submitted one aliquot of plasma.
|
3 MRI counts all participants who completed the T1.
|
|
Note:
|
Current month captures calendar month. The % columns calculate percentage of target, with all sites having common targets.
|
Demographics
|
metric
|
CU
|
LA
|
UP
|
UT
|
WU
|
p
|
|
sex (M:F:O)
|
4:8
|
9:3
|
1:22
|
5:11
|
7:12
|
0.001
|
|
ethnicity (H:NH)
|
3:9
|
1:11
|
1:22
|
1:15
|
0:19
|
0.117
|
|
race (minority:non-minority)
|
4:8
|
1:11
|
3:20
|
1:15
|
3:16
|
0.319
|
|
age
|
67.08 (4.32)
|
68.42 (6.01)
|
67.61 (5.61)
|
71.25 (4.86)
|
68.84 (5.74)
|
0.239
|
|
education
|
14.20 (4.94)
|
16.25 (3.49)
|
15.13 (2.58)
|
15.60 (2.82)
|
16.11 (2.23)
|
0.472
|
|
Note:
|
|
These values represent all participants consented at the OPTIMUM-Neuro baseline visit. It does not take into account the participants who consented but did not meet enrollment criteria, and/or who later terminated. Values in brackets are standard deviation. The p values result from Chi-squared for categorical variables and omnibus ANOVA for continuous variables.
|