INTERIM REPORT ON
THE OUTCOME OF COGNITIVE ASSESSMENT IN STUDY 7009
Longitudinal
cognition follow-up and serial DNA/RNA/SERUM/PLASMA/URINE with or without CSF
banking in normal subjects aged 60 to 75 years
Sponsor: PRECISIONMED,
INC
132 North
Acacia Avenue
Solana
Beach, California 92075
Report Prepared by: Catherine
Deeprose and Keith Wesnes
Cognitive
Drug Research Ltd,
CDR House,
Gatehampton Road,
Goring-on-Thames,
RG8 0EN, UK
Tel:
+44 1491 878700
Fax:
+44 1491 878701
Report Status: Interim
3
Date:
October 2007
Contents
1............. summary. 3
1.1.......... DATA COLLECTED.. 3
1.2.......... BASELINE CHARACTERISTICS.. 3
1.3.......... TEST-RETEST RELIABILITY. 4
1.3.1....... Test-retest and change analyses. 4
1.4.......... INDIVIDUAL DECLINE / IMPAIRMENT. 5
2............. DISCUSSION.. 6
3............. REFERENCES.. 6
For
the third interim report CDR data are reported for 73 subjects at Visit 1
(baseline mean age 66.6, SD 5.71), for 52 subjects at Visit 2 (first follow-up
mean age 66.8, SD 6.01), and for 8 subjects at Visit 3 (second follow-up mean
age 68.5, SD 5.88). Age data were only available for 72 subjects at Visit 1, as
age was not available for subject 7090068 who had data at baseline only.
The mean baseline performance indicated
that the healthy elderly subjects recruited into the present study had similar performance
levels compared to CDR normative data for the same age range, with performance
within one standard deviation of control data.
Table 1 Baseline Characteristics
|
|
Range 58 to 83
Mean 66.6 (5.71)
|
Range 58 to 83
Mean 67.6 (5.67)
|
|
|
|
|
|
|
|
|
Power of
Attention (msec)
|
73
|
1252
(148.0)
|
1176
|
1197
(127)
|
|
Continuity of
Attention (#)
|
73
|
91.6
(2.90)
|
1177
|
89.7
(4.82)
|
|
Quality of Working Memory (SI)
|
73
|
1.72
(0.229)
|
620
|
1.56
(0.386)
|
|
Quality of Episodic Secondary Memory (SI)
|
73
|
2.43
(0.323)
|
N/A
|
N/A
|
|
Speed of Memory (msec)
|
73
|
4984
(906.3)
|
N/A
|
N/A
|
|
Paired Associates Learning Easy Pairs Accuracy
|
73
|
92.1
(12.41)
|
N/A
|
N/A
|
|
Paired Associates Learning Hard Pairs Accuracy
|
73
|
86.64
(16.18)
|
N/A
|
N/A
|
|
|
|
|
|
|
|
Test-retest reliability was generally good
(>0.5 at Visit 2 and >0.7 at Visit 3) for the five composite scores with
the exception of Continuity of Attention, though this is likely due to a
restricted data range. Greatest test-retest reliability was seen for Power of
Attention, with the Spearman correlation coefficient >0.8 from Visit 1 to
Visit 2 and >0.7 from Visit 2 to Visit 3 indicating high levels of
test-retest reliability.
Table
2 Analysis Summary
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Power of Attention (msec)
|
1245
(146.6)
|
0.824
(P<0.001)
|
1.69
(86.5)
|
1229
(83.3)
|
0.786
(P=0.021)
|
54.9
(72.8)
|
|
Continuity of Attention (#)
|
90.5
(4.14)
|
0.39
(P=0.004)
|
-0.75
(3.31)
|
93.1
(0.99)
|
-0.097
(P=0.819)
|
1.87
(1.13)
|
|
Quality Working Memory (#)
|
1.76
(0.244)
|
0.60
(P<0.001)
|
0.06
(0.192)
|
1.76
(0.200)
|
0.74
(P=0.366)
|
0.07
(0.205)
|
|
Quality of Episodic Secondary Memory (#)
|
2.40
(0.293)
|
0.52
(P<0.001)
|
-0.04
(0.292)
|
2.60
(0.235)
|
0.88
(P=0.004)
|
-0.01
(0.104)
|
|
Speed of Memory (msec)
|
4632
(776.7)
|
0.64
(P<0.001)
|
-266
(778.7)
|
4519
(694.9)
|
0.69
(P=0.058)
|
-47
(547.1)
|
|
Paired Associates Learning Easy Pairs Accuracy
|
99.0
(4.86)
|
0.12
(P=0.415)
|
5.29
(11.44)
|
100
(*)
|
*
|
3.13
(8.84)
|
