Trial Outcomes & Findings for Semantic Memory, Financial Capacity, and Brain Perfusion in Mild Cognitive Impairment (MCI) (CASL) (NCT NCT00880555)
NCT ID: NCT00880555
Last Updated: 2016-03-24
Results Overview
At each research visit, participants undertook 5 portions of the Financial Capacity Instrument (Domains 2, 3, 4b, 5, and 7). We report the total FCI score across the five domains tested, which has a range of possible scores from 0-191. Higher scores reflect greater capacity for understanding financial concepts and handling financial tasks.
Recruitment status
COMPLETED
Target enrollment
78 participants
Primary outcome timeframe
Year 1, Year 2, Year 3
Results posted on
2016-03-24
Participant Flow
All individuals underwent baseline MRI, cognitive, and functional assessment. Four individuals (2 cognitive impairment- non dementia (CIND), 1 intoxicated, 1 with non-AD dementia) determined not to fit into one of the study arms (MCI, mild AD, or cognitively normal) were not asked to return for follow up cognitive and functional assessment.
Participant milestones
| Measure |
Arm 1: Non-Dementia Memory Disorder
Elderly patients with non-dementia memory disorder (mild cognitive impairment)
|
Arm 2: Control
Elderly controls without memory impairment
|
Arm 3: Mild Alzheimer Disease
Patients with mild Alzheimer disease (but preserved routine activities of daily living)
|
CIND
Individuals with cognitive impairment who did not meet criteria for MCI or dementia
|
Intoxicated
Individuals who appeared to be intoxicated at baseline evaluation
|
Non-AD Dementia
Other causes of dementia
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
40
|
11
|
2
|
1
|
1
|
|
Overall Study
COMPLETED
|
13
|
23
|
6
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
17
|
5
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm 1: Non-Dementia Memory Disorder
Elderly patients with non-dementia memory disorder (mild cognitive impairment)
|
Arm 2: Control
Elderly controls without memory impairment
|
Arm 3: Mild Alzheimer Disease
Patients with mild Alzheimer disease (but preserved routine activities of daily living)
|
CIND
Individuals with cognitive impairment who did not meet criteria for MCI or dementia
|
Intoxicated
Individuals who appeared to be intoxicated at baseline evaluation
|
Non-AD Dementia
Other causes of dementia
|
|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
8
|
0
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lack of resources (hired rater)
|
9
|
7
|
5
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Semantic Memory, Financial Capacity, and Brain Perfusion in Mild Cognitive Impairment (MCI) (CASL)
Baseline characteristics by cohort
| Measure |
Arm 1: Non-Dementia Memory Disorder
n=23 Participants
Elderly patients with non-dementia memory disorder (mild cognitive impairment)
|
Arm 2: Control
n=40 Participants
Elderly controls without memory impairment
|
Arm 3: Mild Alzheimer Disease
n=11 Participants
Patients with mild Alzheimer disease (but preserved routine activities of daily living)
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.91 years
STANDARD_DEVIATION 7.63 • n=93 Participants
|
65.08 years
STANDARD_DEVIATION 9.46 • n=4 Participants
|
74.18 years
STANDARD_DEVIATION 6.29 • n=27 Participants
|
68.55 years
STANDARD_DEVIATION 9.26 • n=483 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
44 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
65 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Educational level
|
14.9 years
STANDARD_DEVIATION 2.94 • n=93 Participants
|
16.0 years
STANDARD_DEVIATION 2.39 • n=4 Participants
|
14.8 years
STANDARD_DEVIATION 2.36 • n=27 Participants
|
15.4 years
STANDARD_DEVIATION 2.6 • n=483 Participants
|
|
Verbal learning - 1st immediate list A
|
5.0 words recalled
STANDARD_DEVIATION 1.7 • n=93 Participants
|
6.4 words recalled
STANDARD_DEVIATION 2.2 • n=4 Participants
|
3.3 words recalled
STANDARD_DEVIATION 1.4 • n=27 Participants
|
5.4 words recalled
STANDARD_DEVIATION 2.2 • n=483 Participants
|
|
Verbal learning - list B immediate recall
|
4.5 words recalled
STANDARD_DEVIATION 1.4 • n=93 Participants
|
5.5 words recalled
STANDARD_DEVIATION 2.2 • n=4 Participants
|
2.7 words recalled
STANDARD_DEVIATION 1.3 • n=27 Participants
|
4.7 words recalled
STANDARD_DEVIATION 2.0 • n=483 Participants
|
|
Verbal learning - total trials 1-5
|
35.9 words recalled
STANDARD_DEVIATION 9.6 • n=93 Participants
|
48.7 words recalled
STANDARD_DEVIATION 10.0 • n=4 Participants
|
23.0 words recalled
STANDARD_DEVIATION 8.2 • n=27 Participants
|
40.5 words recalled
STANDARD_DEVIATION 13.2 • n=483 Participants
|
|
Verbal learning - long delay free recall
|
5.8 words recalled
STANDARD_DEVIATION 3.9 • n=93 Participants
|
10.3 words recalled
STANDARD_DEVIATION 3.5 • n=4 Participants
|
1.6 words recalled
STANDARD_DEVIATION 2.0 • n=27 Participants
|
7.5 words recalled
STANDARD_DEVIATION 4.6 • n=483 Participants
|
|
Verbal learning - long delay cued recall
|
7.3 words recalled
STANDARD_DEVIATION 3.7 • n=93 Participants
|
11.2 words recalled
STANDARD_DEVIATION 3.2 • n=4 Participants
|
3.3 words recalled
STANDARD_DEVIATION 2.4 • n=27 Participants
|
8.7 words recalled
STANDARD_DEVIATION 4.3 • n=483 Participants
|
|
10/36 spatial recall - 1st trial
|
4.3 positions recalled
STANDARD_DEVIATION 2.0 • n=93 Participants
|
5.6 positions recalled
STANDARD_DEVIATION 2.0 • n=4 Participants
|
4.0 positions recalled
STANDARD_DEVIATION 1.6 • n=27 Participants
|
5.0 positions recalled
STANDARD_DEVIATION 2.0 • n=483 Participants
|
|
10/36 spatial recall - total
|
15.9 positions recalled
STANDARD_DEVIATION 5.0 • n=93 Participants
|
20.2 positions recalled
STANDARD_DEVIATION 5.0 • n=4 Participants
|
13.8 positions recalled
STANDARD_DEVIATION 3.0 • n=27 Participants
|
17.9 positions recalled
STANDARD_DEVIATION 5.3 • n=483 Participants
|
|
10/36 spatial recall - delayed recall
|
5.2 positions recalled
STANDARD_DEVIATION 2.2 • n=93 Participants
|
7.2 positions recalled
STANDARD_DEVIATION 2.4 • n=4 Participants
|
5.4 positions recalled
STANDARD_DEVIATION 1.7 • n=27 Participants
|
6.4 positions recalled
STANDARD_DEVIATION 2.4 • n=483 Participants
|
|
F-, A-, and S-words
|
29.1 words generated
STANDARD_DEVIATION 14.5 • n=93 Participants
|
36.4 words generated
STANDARD_DEVIATION 11.4 • n=4 Participants
|
27.5 words generated
STANDARD_DEVIATION 14.0 • n=27 Participants
|
32.5 words generated
STANDARD_DEVIATION 13.2 • n=483 Participants
|
|
Semantic fluency (7 categories)
|
74.6 words generated
STANDARD_DEVIATION 25.7 • n=93 Participants
|
101.1 words generated
STANDARD_DEVIATION 23.3 • n=4 Participants
|
61.5 words generated
STANDARD_DEVIATION 25.9 • n=27 Participants
|
86.2 words generated
STANDARD_DEVIATION 28.5 • n=483 Participants
|
|
Trail Making Test - A
|
45.4 seconds
STANDARD_DEVIATION 13.8 • n=93 Participants
|
34.7 seconds
STANDARD_DEVIATION 11.4 • n=4 Participants
|
77.0 seconds
STANDARD_DEVIATION 67.7 • n=27 Participants
|
44.0 seconds
STANDARD_DEVIATION 30.1 • n=483 Participants
|
|
Trail Making Test - B
|
132.2 seconds
STANDARD_DEVIATION 64.4 • n=93 Participants
|
78.8 seconds
STANDARD_DEVIATION 25.5 • n=4 Participants
|
178.7 seconds
STANDARD_DEVIATION 79.2 • n=27 Participants
|
110.8 seconds
STANDARD_DEVIATION 63.6 • n=483 Participants
|
|
Boston Naming Test - 30 item
|
25.6 pictures named
STANDARD_DEVIATION 4.1 • n=93 Participants
|
27.2 pictures named
STANDARD_DEVIATION 2.2 • n=4 Participants
|
21.6 pictures named
STANDARD_DEVIATION 5.7 • n=27 Participants
|
25.8 pictures named
STANDARD_DEVIATION 4.0 • n=483 Participants
|
|
Pyramids and Palm Trees - pictures
|
49.4 correct matches
STANDARD_DEVIATION 1.5 • n=93 Participants
|
49.6 correct matches
STANDARD_DEVIATION 1.4 • n=4 Participants
|
46.4 correct matches
STANDARD_DEVIATION 5.1 • n=27 Participants
|
48.9 correct matches
STANDARD_DEVIATION 2.6 • n=483 Participants
|
|
Pyramids and Palm Trees - words
|
50.0 correct matches
STANDARD_DEVIATION 1.8 • n=93 Participants
|
50.4 correct matches
STANDARD_DEVIATION 1.2 • n=4 Participants
|
48.4 correct matches
STANDARD_DEVIATION 4.9 • n=27 Participants
|
49.9 correct matches
STANDARD_DEVIATION 2.5 • n=483 Participants
|
|
Extended Mini-Mental State Exam
|
44.2 points awarded for correct items
STANDARD_DEVIATION 4.9 • n=93 Participants
|
47.6 points awarded for correct items
STANDARD_DEVIATION 2.5 • n=4 Participants
|
36.5 points awarded for correct items
STANDARD_DEVIATION 4.4 • n=27 Participants
|
44.7 points awarded for correct items
STANDARD_DEVIATION 5.2 • n=483 Participants
|
|
Financial Capacity Instrument - total
|
151.8 points awarded for correct items
STANDARD_DEVIATION 17.3 • n=93 Participants
|
160.2 points awarded for correct items
STANDARD_DEVIATION 8.3 • n=4 Participants
|
127.1 points awarded for correct items
STANDARD_DEVIATION 27.9 • n=27 Participants
|
152.4 points awarded for correct items
STANDARD_DEVIATION 19.0 • n=483 Participants
|
PRIMARY outcome
Timeframe: Year 1, Year 2, Year 3Population: Individuals completing at least one assessment following baseline
At each research visit, participants undertook 5 portions of the Financial Capacity Instrument (Domains 2, 3, 4b, 5, and 7). We report the total FCI score across the five domains tested, which has a range of possible scores from 0-191. Higher scores reflect greater capacity for understanding financial concepts and handling financial tasks.
Outcome measures
| Measure |
Arm 1: Non-Dementia Memory Disorder
n=10 Participants
Elderly patients with non-dementia memory disorder (mild cognitive impairment)
|
Arm 2: Control
n=22 Participants
Elderly controls without memory impairment
|
Arm 3: Mild Alzheimer Disease
n=6 Participants
Patients with mild Alzheimer disease (but preserved routine activities of daily living)
|
|---|---|---|---|
|
FCI Score at Follow-up
Year 1
|
147.3 points awarded for correct items
Standard Deviation 19.7
|
164.0 points awarded for correct items
Standard Deviation 13.3
|
123.3 points awarded for correct items
Standard Deviation 43.1
|
|
FCI Score at Follow-up
Year 2
|
150.8 points awarded for correct items
Standard Deviation 9.0
|
179.0 points awarded for correct items
Standard Deviation 6.2
|
0 points awarded for correct items
Standard Deviation 0
|
|
FCI Score at Follow-up
Year 3
|
93 points awarded for correct items
Standard Deviation 0
|
163 points awarded for correct items
Standard Deviation 0
|
0 points awarded for correct items
Standard Deviation 0
|
Adverse Events
Arm 1: Non-Dementia Memory Disorder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3: Mild Alzheimer Disease
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CIND
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intoxicated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-AD Dementia
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Non-Dementia Memory Disorder
n=23 participants at risk
Elderly patients with non-dementia memory disorder (mild cognitive impairment)
|
Arm 2: Control
n=40 participants at risk
Elderly controls without memory impairment
|
Arm 3: Mild Alzheimer Disease
n=11 participants at risk
Patients with mild Alzheimer disease (but preserved routine activities of daily living)
|
CIND
n=2 participants at risk
Individuals with cognitive impairment who did not meet criteria for MCI or dementia
|
Intoxicated
n=1 participants at risk
Individuals who appeared to be intoxicated at baseline evaluation
|
Non-AD Dementia
n=1 participants at risk
Other causes of dementia
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Death
|
0.00%
0/23 • 1 year
Potential adverse events were discussed at each research visit. For some patients, adverse events were detected through clinical interaction with the participants.
|
0.00%
0/40 • 1 year
Potential adverse events were discussed at each research visit. For some patients, adverse events were detected through clinical interaction with the participants.
|
0.00%
0/11 • 1 year
Potential adverse events were discussed at each research visit. For some patients, adverse events were detected through clinical interaction with the participants.
|
0.00%
0/2 • 1 year
Potential adverse events were discussed at each research visit. For some patients, adverse events were detected through clinical interaction with the participants.
|
0.00%
0/1 • 1 year
Potential adverse events were discussed at each research visit. For some patients, adverse events were detected through clinical interaction with the participants.
|
100.0%
1/1 • Number of events 1 • 1 year
Potential adverse events were discussed at each research visit. For some patients, adverse events were detected through clinical interaction with the participants.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place