Trial Outcomes & Findings for Mayo Acute Stroke Trial for Enhancing Recovery (NCT NCT00805792)
NCT ID: NCT00805792
Last Updated: 2021-07-30
Results Overview
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).
COMPLETED
PHASE2
33 participants
90 days post-stroke
2021-07-30
Participant Flow
Enrollment extended from November 2008 through April 2010. The study was conducted at the Mayo Clinic sites in Jacksonville, FL and Rochester, MN.
Participant milestones
| Measure |
Donepezil
Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Donepezil
Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Mayo Acute Stroke Trial for Enhancing Recovery
Baseline characteristics by cohort
| Measure |
Donepezil
n=33 Participants
Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
|
|---|---|
|
Age, Continuous
|
66 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=99 Participants
|
|
Number of Participants with Previous Ischemic Stroke
Previous ischemic stroke
|
5 participants
n=99 Participants
|
|
Number of Participants with Previous Ischemic Stroke
No previous ischemic stroke
|
28 participants
n=99 Participants
|
|
Body Mass Index
|
27.1 kg/m^2
n=99 Participants
|
|
Participant Scores on National Institutes of Health Stroke Scale
Mild (<6)
|
16 participants
n=99 Participants
|
|
Participant Scores on National Institutes of Health Stroke Scale
Moderate (6-13)
|
12 participants
n=99 Participants
|
|
Participant Scores on National Institutes of Health Stroke Scale
Severe (>13)
|
5 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 90 days post-strokePopulation: Intention-to-treat analysis, all treated participants (n=33). Unobserved because of death (n=3) or loss to follow up (N=2) treated as nonresponse.
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).
Outcome measures
| Measure |
Donepezil
n=33 Participants
Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
|
|---|---|
|
Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at Day 90
Stroke severity (NIHSS) mild (<6) (n=11/16)
|
69 percentage of participants
|
|
Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at Day 90
Stroke severity (NIHSS) moderate (6-13) (n=4/12)
|
33 percentage of participants
|
|
Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at Day 90
Stroke severity (NIHSS) severe (>13) (n=0/5)
|
0 percentage of participants
|
|
Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at Day 90
Overall (n=15/33)
|
45 percentage of participants
|
SECONDARY outcome
Timeframe: baseline, 90 days post-strokeThe National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).
Outcome measures
| Measure |
Donepezil
n=33 Participants
Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
|
|---|---|
|
Change in Mean National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days Post-stroke
|
-2.8 units on a scale
Standard Error 0.8
|
SECONDARY outcome
Timeframe: baseline, 90 days post-strokeThe Barthel Index of Activities of Daily Living (ADLs) measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.
Outcome measures
| Measure |
Donepezil
n=33 Participants
Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
|
|---|---|
|
Change in Mean Barthel Index of Activities of Daily Living Score at 90 Days Post-stroke
|
21.4 units on a scale
Standard Error 5.2
|
SECONDARY outcome
Timeframe: baseline, 90 days post-strokeThe mini-mental state examination (MMSE) is a 30-point questionnaire test that is used to screen for cognitive impairment. The questionnaire samples functions including arithmetic, memory and orientation to time and place. Scores range from 0 to 30. Any score greater than or equal to 25 points is effectively normal (intact). Below this, scores can indicate severe (≤9 points), moderate (10-20 points) or mild (21-24 points) cognitive impairment.
Outcome measures
| Measure |
Donepezil
n=33 Participants
Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
|
|---|---|
|
Change in Mean Score on Mini Mental State Exam at 90 Days Post-stroke
|
4.4 units on a scale
Standard Error 1.2
|
SECONDARY outcome
Timeframe: baseline, 90 days post-strokeThe Trail-making test consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. It can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. There are two parts to the test: A, in which the targets are all numbers (1,2,3, etc.)and the test taker needs to connect them in sequential order, and B, in which the subject alternates between numbers and letters (1, A, 2, B, etc.).
Outcome measures
| Measure |
Donepezil
n=33 Participants
Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
|
|---|---|
|
Change in Time to Complete Neuropsychological Trail Making Tests A and B at 90 Days Post-stroke
Trail Making Test A
|
-43.4 seconds
Standard Error 9.2
|
|
Change in Time to Complete Neuropsychological Trail Making Tests A and B at 90 Days Post-stroke
Trail Making Test B
|
-67.3 seconds
Standard Error 13.3
|
Adverse Events
Donepezil
Serious adverse events
| Measure |
Donepezil
n=33 participants at risk
Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
|
|---|---|
|
General disorders
Death
|
9.1%
3/33 • Number of events 3 • Adverse events were collected during the 90-day course of therapy.
|
|
Vascular disorders
Recurrent stroke
|
6.1%
2/33 • Number of events 2 • Adverse events were collected during the 90-day course of therapy.
|
|
Vascular disorders
Transient ischemic attack
|
3.0%
1/33 • Number of events 1 • Adverse events were collected during the 90-day course of therapy.
|
|
Cardiac disorders
Myocardial infarction
|
3.0%
1/33 • Number of events 1 • Adverse events were collected during the 90-day course of therapy.
|
|
Vascular disorders
Carotid angioplasty and stent placement
|
3.0%
1/33 • Number of events 1 • Adverse events were collected during the 90-day course of therapy.
|
|
Cardiac disorders
Hypertension
|
3.0%
1/33 • Number of events 1 • Adverse events were collected during the 90-day course of therapy.
|
|
Musculoskeletal and connective tissue disorders
Chest pain/leg cramps
|
3.0%
1/33 • Number of events 1 • Adverse events were collected during the 90-day course of therapy.
|
Other adverse events
| Measure |
Donepezil
n=33 participants at risk
Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
|
|---|---|
|
General disorders
Fatigue
|
51.5%
17/33 • Number of events 17 • Adverse events were collected during the 90-day course of therapy.
|
|
General disorders
Insomnia
|
48.5%
16/33 • Number of events 16 • Adverse events were collected during the 90-day course of therapy.
|
|
Psychiatric disorders
Depression
|
39.4%
13/33 • Number of events 13 • Adverse events were collected during the 90-day course of therapy.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
11/33 • Number of events 11 • Adverse events were collected during the 90-day course of therapy.
|
|
Gastrointestinal disorders
Loss of appetite
|
30.3%
10/33 • Number of events 10 • Adverse events were collected during the 90-day course of therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
30.3%
10/33 • Number of events 10 • Adverse events were collected during the 90-day course of therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place