Trial Outcomes & Findings for Detecting an Early Response to Donepezil With Measures of Visual Attention (NCT NCT03073876)
NCT ID: NCT03073876
Last Updated: 2021-02-04
Results Overview
Computerized attention task measures response time to detect a target presented at varied interstimulus intervals (350ms and 500ms). Participants respond to centrally presented asterisk on computer screen. Time elapsed from prior stimulus (= interstimulus interval) indicates when prior stimulus was presented. xx
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
25 participants
Primary outcome timeframe
Baseline to 6 weeks
Results posted on
2021-02-04
Participant Flow
Of 25 individuals enrolled, 2 participants allocated to the placebo group discontinued: one complained of side-effects (n = 1); one moved from NY area (n = 1). Total N= 23.
Participant milestones
| Measure |
Drug
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Detecting an Early Response to Donepezil With Measures of Visual Attention
Baseline characteristics by cohort
| Measure |
Drug
n=12 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
n=11 Participants
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
Total
n=23 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Mini Mental State Examination (MMSE)
|
24.3 units on a scale
STANDARD_DEVIATION 3.5 • n=5 Participants
|
25.4 units on a scale
STANDARD_DEVIATION 1.7 • n=7 Participants
|
24.9 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Dementia Rating Scale (DRS)
|
119.7 units on a scale
STANDARD_DEVIATION 10.4 • n=5 Participants
|
127.1 units on a scale
STANDARD_DEVIATION 7.2 • n=7 Participants
|
123.4 units on a scale
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Clinical Dementia Rating Scale (CDRS)
|
1 units on a scale
STANDARD_DEVIATION .4 • n=5 Participants
|
3 units on a scale
STANDARD_DEVIATION .4 • n=7 Participants
|
1.9 units on a scale
STANDARD_DEVIATION .41 • n=5 Participants
|
|
Geriatric Depression Scale (GDS)
|
6.7 units on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 4.5 • n=7 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Neuropsychiatric Inventory (NPI)
|
16.7 units on a scale
STANDARD_DEVIATION 12.3 • n=5 Participants
|
15.4 units on a scale
STANDARD_DEVIATION 15.8 • n=7 Participants
|
16.1 units on a scale
STANDARD_DEVIATION 14.1 • n=5 Participants
|
|
ADAS- Cog
|
17.3 units on a scale
STANDARD_DEVIATION 6.6 • n=5 Participants
|
13.1 units on a scale
STANDARD_DEVIATION 3.8 • n=7 Participants
|
15.2 units on a scale
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
HVLT Learning
|
11 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
11.4 units on a scale
STANDARD_DEVIATION 3.8 • n=7 Participants
|
11.2 units on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
HVLT delay Recall
|
1.2 units on a scale
STANDARD_DEVIATION 1 • n=5 Participants
|
1.1 units on a scale
STANDARD_DEVIATION 1.4 • n=7 Participants
|
1.1 units on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
HVLT Recognition
|
5.3 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
6.7 units on a scale
STANDARD_DEVIATION 2.7 • n=7 Participants
|
6.0 units on a scale
STANDARD_DEVIATION 3.15 • n=5 Participants
|
|
Letter Fluency
|
9.0 units on a scale
STANDARD_DEVIATION 5.0 • n=5 Participants
|
9.4 units on a scale
STANDARD_DEVIATION 4.3 • n=7 Participants
|
9.2 units on a scale
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Category Fluency
|
7.4 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
7.9 units on a scale
STANDARD_DEVIATION 2.7 • n=7 Participants
|
7.5 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Visual Form Discrimination
|
26.7 units on a scale
STANDARD_DEVIATION 3.9 • n=5 Participants
|
27.9 units on a scale
STANDARD_DEVIATION 2.5 • n=7 Participants
|
27.3 units on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Digit Span Forward (max)
|
5.9 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
6.0 units on a scale
STANDARD_DEVIATION 0.8 • n=7 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Digit Span Backward (max)
|
3.6 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
6.0 units on a scale
STANDARD_DEVIATION 0.8 • n=7 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
DKEFS Trail Making Test-4
|
12.2 units on a scale
STANDARD_DEVIATION 11.7 • n=5 Participants
|
6.7 units on a scale
STANDARD_DEVIATION 6.2 • n=7 Participants
|
9.5 units on a scale
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
DKEFS Trail Making Test-5
|
62.7 units on a scale
STANDARD_DEVIATION 36.5 • n=5 Participants
|
54.3 units on a scale
STANDARD_DEVIATION 16.6 • n=7 Participants
|
58.5 units on a scale
STANDARD_DEVIATION 26.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 weeksComputerized attention task measures response time to detect a target presented at varied interstimulus intervals (350ms and 500ms). Participants respond to centrally presented asterisk on computer screen. Time elapsed from prior stimulus (= interstimulus interval) indicates when prior stimulus was presented. xx
Outcome measures
| Measure |
Drug
n=12 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
n=11 Participants
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
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|---|---|---|
|
Change in Foreperiod Effect Task - Processing Speed
350
|
42 response time in msec
Standard Deviation 176.3
|
13 response time in msec
Standard Deviation 9
|
|
Change in Foreperiod Effect Task - Processing Speed
500
|
33 response time in msec
Standard Deviation 176.7
|
13 response time in msec
Standard Deviation 9
|
PRIMARY outcome
Timeframe: Baseline to 6 weeksComputerized attention task measuring response time to detect a target after a spatial orienting cues of either valid (cue on same side in space as target) or Invalid Cue (cue on opposite side of space as target). Longer response time (msec) indicates worse performance.
Outcome measures
| Measure |
Drug
n=11 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
n=12 Participants
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
|
Change in Covert Orienting Task
|
496.5 milliseconds
Interval 414.6 to 578.4
|
452.5 milliseconds
Interval 401.7 to 503.3
|
PRIMARY outcome
Timeframe: Baseline to 6 weeksComputerized attention task measures the accuracy of reporting stimuli presented at time intervals, varying load. Faster reaction time and accuracy represents better performance.
Outcome measures
| Measure |
Drug
n=23 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
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|---|---|---|
|
Change in Attentional Blink Task Baseline to 6 Weeks - Stimulus Onset Asynchrony (SOA) 266ms
|
-.06 milliseconds
Standard Deviation .32
|
—
|
PRIMARY outcome
Timeframe: Baseline to 6 weeksComputerized attention task measures the accuracy of reporting stimuli presented within 399 ms interval. Higher accuracy represents better performance.
Outcome measures
| Measure |
Drug
n=23 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
|
Change in Attentional Blink Task Baseline to 6 Weeks - SOA 399ms
|
-.022 milliseconds
Standard Deviation .33
|
—
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsChange of Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog); primary outcome measure of drug efficacy. Minimum value = 0, maximum value = 70. Higher scores represent worse cognitive functioning.
Outcome measures
| Measure |
Drug
n=23 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
|
Change of ADAS-COG From Baseline to 6 Months
|
-.29 units on a scale
Standard Deviation 4.70
|
—
|
PRIMARY outcome
Timeframe: 6 weeksComputerized attention task measures reaction time (RT) to detect a target presented at varied interstimulus interval comparing Block 1 (presented at beginning of session) and Block 2 (presented at end of session)
Outcome measures
| Measure |
Drug
n=12 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
n=11 Participants
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
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Foreperiod Effect Task at 6 Weeks - Fatigue (Blocks 1 & 2)
Block 1
|
400 msec
Standard Deviation 87.4
|
331 msec
Standard Deviation 200.7
|
|
Foreperiod Effect Task at 6 Weeks - Fatigue (Blocks 1 & 2)
Block 2
|
395 msec
Standard Deviation 85.3
|
385 msec
Standard Deviation 254.2
|
PRIMARY outcome
Timeframe: Baseline to 6 weeksComputerized attention task measures the variability (SD) in response time to detect a target presented at varied interstimulus intervals (350ms and 500ms)
Outcome measures
| Measure |
Drug
n=12 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
n=10 Participants
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
|
Change in Foreperiod Effect Task - Variability (350ms & 500ms)
350ms
|
-26.7 msec
Standard Deviation 42.97
|
-4.5 msec
Standard Deviation 34.44
|
|
Change in Foreperiod Effect Task - Variability (350ms & 500ms)
500ms
|
28.46 msec
Standard Deviation 110.63
|
8.37 msec
Standard Deviation 39.73
|
PRIMARY outcome
Timeframe: 6 weeksComputerized attention task measures response time to detect a target across blocks of stimuli. Data shown for performance at Block1 and Block5
Outcome measures
| Measure |
Drug
n=12 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
n=11 Participants
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
|
Covert Orienting at 6 Weeks - Fatigue Across Blocks
Block 1
|
415 msec
Standard Deviation 145.1
|
402 msec
Standard Deviation 95.1
|
|
Covert Orienting at 6 Weeks - Fatigue Across Blocks
Block 5
|
451 msec
Standard Deviation 134.2
|
487 msec
Standard Deviation 144.3
|
PRIMARY outcome
Timeframe: 6 monthsNeuropsychiatric Inventory (NPI) is a scale that measures neuropsychiatric symptoms. We reported a score that captures the frequency of each symptom multiplied by the severity rating score. Scores range from 0 - 144; Higher scores represent worse outcomes.
Outcome measures
| Measure |
Drug
n=23 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
|
Neuropsychiatric Inventory Score
|
14.09 score on a scale
Standard Deviation 14.26
|
—
|
PRIMARY outcome
Timeframe: 6 monthsScale of instrumental activities of daily living (IADLs), adapted from Lawton Brody scale. Caregiver rates 8 functional items from 0-2 severity. Total score is the sum of ratings for each item. Total score ranges from 0 (minimum) to 16 (maximum) with higher scores representing worse functional outcomes.
Outcome measures
| Measure |
Drug
n=23 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
|
Instrumental Activities of Daily Living
|
6.54 units on a scale
Standard Deviation 4.23
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksDementia Rating Scale (DRS) change score (performance at 6 weeks minus performance at baseline). This is a global measure of cognitive function. Scores range from 0 - 144; higher scores represent better cognitive functioning.
Outcome measures
| Measure |
Drug
n=12 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
n=11 Participants
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
|
Change in Dementia Rating Scale
|
1.67 units on a scale
Standard Deviation 6.91
|
-.54 units on a scale
Standard Deviation 6.27
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksMini Mental Status Examination (MMSE) is a commonly used cognitive screener. Scores range from 0-30; higher scores mean better cognitive functioning.
Outcome measures
| Measure |
Drug
n=12 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
n=10 Participants
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
|
Mini Mental Status Examination
|
-.17 units on a scale
Standard Deviation 2.44
|
-1.09 units on a scale
Standard Deviation 2.02
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksChange of Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog); primary outcome measure of drug efficacy. Minimum value = 0, maximum value = 70. Higher scores represent worse cognitive functioning.
Outcome measures
| Measure |
Drug
n=12 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
n=10 Participants
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
|
Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)
|
-1.90 score on a scale
Standard Deviation 4.92
|
.99 score on a scale
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksThis measure represents the change in the variable longest Digit Span Forward (LDSF) from baseline to 6 weeks. Score represents the maximum length of number repeated in the forward condition. Score ranges from 0 to 9. Higher scores represent better outcome.
Outcome measures
| Measure |
Drug
n=12 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
n=10 Participants
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
|
Change in Digit Span Forward
|
-0.6 units on a scale
Standard Deviation 1
|
-0.4 units on a scale
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksHopkins Verbal Learning Test- Revised (HVLT-R) (Brandt, 1991) is a list-learning task. Recall variable is computed by adding the number of words repeated in each of the three learning trials. Raw scores of each measure were used in the analyses. Total Recall ranges from 0-30. Higher scores represent better outcome.
Outcome measures
| Measure |
Drug
n=12 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
n=10 Participants
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
|
Change in Hopkins Verbal Learning Test- Revised - Recall
|
.17 score on a scale
Standard Deviation 1.8
|
.40 score on a scale
Standard Deviation 4.79
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksLetter fluency (FAS) (Benton, 1967) was selected to assess speed of verbal generativity. Participants are required to generate words that start with a particular letter (excluding n; three trials (words starting with 'F', 'A', 'S' each for 1 minute minutes) are administered. Higher performance is better with range from 0 to unlimited.
Outcome measures
| Measure |
Drug
n=12 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
n=9 Participants
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
|
Change in Language Function Assessed With the Letter Fluency Test
|
.003 score on a scale
Standard Deviation 1.51
|
.17 score on a scale
Standard Deviation 2.52
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksThe Delis-Kaplan Executive Function (D-KEFS Trail) Subtest 4: Number-Letter Switching Scaled Score was used to assess executive functioning. Scaled scores range from 1-19. Higher scores represent less impairment (below 8 = low; 8-12 = average; \> 12 = above average). Scores represent seconds to complete the task. Faster performance is better.
Outcome measures
| Measure |
Drug
n=12 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
n=10 Participants
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
|
Change on Trail Making Test - Condition
|
-1.67 units on a scale
Standard Deviation 39.45
|
-2.3 units on a scale
Standard Deviation 41.46
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksMeasure of visuospatial function requiring matching designs from the Benton Visual Form Discrimination test. Total scores is calculated by adding the number of items correct. Total score ranges from 0-32, higher score is better.
Outcome measures
| Measure |
Drug
n=12 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
n=11 Participants
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
|
Change in Visual Form Discrimination
|
.92 score on a scale
Standard Deviation 3.09
|
.33 score on a scale
Standard Deviation 3.94
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksMeasure of language / semantic function. This task requires participants to generate words belonging to specific categories within 1 minute. There are three trials. Total scores is computed by obtaining the mean number of words generated across the three trials (fruits/vegetables/animals). Higher score represents better outcome.
Outcome measures
| Measure |
Drug
n=12 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
n=10 Participants
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
|
Change in Category Fluency Test
|
.17 score on a scale
Standard Deviation 5.56
|
-2.8 score on a scale
Standard Deviation 4.02
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksThis measure represents the change in the variable longest Digit Span Backwards (LDSB) from baseline to 6 weeks. Score represents the maximum length of number repeated in the backward condition. Score ranges from 0 to 8. Higher scores represent better outcome.
Outcome measures
| Measure |
Drug
n=12 Participants
Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
|
Placebo
n=10 Participants
Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.
The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.
Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth
Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
|
|---|---|---|
|
Change in Digit Span Backwards
|
0.5 units on a scale
Standard Deviation 0.8
|
0.1 units on a scale
Standard Deviation 0.75
|
Adverse Events
Drug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nancy S. Foldi, PhD; Professor
City University of New York - Queens College and The Graduate Center
Phone: 718.997.3253
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place