Trial Outcomes & Findings for The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life (NCT NCT00814658)
NCT ID: NCT00814658
Last Updated: 2013-08-26
Results Overview
The Two-choice reaction time test is a computerized attention test in which the numbers one or five were presented in the center of the computer screen in a random order. The patient had to press the correspondent button in the response box as quickly as possible. The patient's right finger was put over the button five and the left finger over button one before the test begun. The reaction time, assessed 100 times per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24.This test is part of the Computerized Neuropsychological Test Battery (CNTB).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
Baseline, Week 8, Week 24
Results posted on
2013-08-26
Participant Flow
22 patients were enrolled in the study, but one (1) patient was excluded from the study because the patient has died before study medication use. Therefore, the study was formed by 21 patients that used at least 1 study medication dose and had at least 1 evaluation after started use (Intention to Treat (ITT) population).
Participant milestones
| Measure |
Galantamine + Nimodipine
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
12
|
|
Overall Study
COMPLETED
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Galantamine + Nimodipine
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Adverse Event
|
3
|
3
|
Baseline Characteristics
The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life
Baseline characteristics by cohort
| Measure |
Galantamine + Nimodipine
n=9 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo
n=12 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
78.1 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
74.3 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
76.0 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8, Week 24Population: Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.
The Simple Reaction Time is a computerized attention test that evaluates the patient's reaction time. The number one was presented in the center of the computer screen and the patient had to press this number in the response box as quickly as possible. The reaction time, assessed 100 times per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24. The patient's finger was put over button one before the test begun. This test is part of the Computerized Neuropsychological Test Battery (CNTB).
Outcome measures
| Measure |
Galantamine + Nimodipine (Baseline)
n=9 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Baseline)
n=12 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 8)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 8)
n=9 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
n=8 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
|---|---|---|---|---|---|---|---|---|
|
Reaction Time for Simple Reaction Time Test at Baseline, Week 8, and Week 24
|
1024.06 milliseconds
Standard Deviation 1307.97
|
729.18 milliseconds
Standard Deviation 394.88
|
466.60 milliseconds
Standard Deviation 297.53
|
671.33 milliseconds
Standard Deviation 298.38
|
467.60 milliseconds
Standard Deviation 336.69
|
584.44 milliseconds
Standard Deviation 320.37
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 8, Week 24Population: Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.
The Two-choice reaction time test is a computerized attention test in which the numbers one or five were presented in the center of the computer screen in a random order. The patient had to press the correspondent button in the response box as quickly as possible. The patient's right finger was put over the button five and the left finger over button one before the test begun. The reaction time, assessed 100 times per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24.This test is part of the Computerized Neuropsychological Test Battery (CNTB).
Outcome measures
| Measure |
Galantamine + Nimodipine (Baseline)
n=9 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Baseline)
n=12 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 8)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 8)
n=9 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
n=8 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
|---|---|---|---|---|---|---|---|---|
|
Reaction Time for Two-choice Reaction Time Test at Baseline, Week 8, and Week 24
|
1919.72 milliseconds
Standard Deviation 1801.13
|
1096.75 milliseconds
Standard Deviation 617.45
|
852.70 milliseconds
Standard Deviation 480.79
|
1187.78 milliseconds
Standard Deviation 637.60
|
727.60 milliseconds
Standard Deviation 375.03
|
1116.25 milliseconds
Standard Deviation 540.91
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 8, Week 24Population: Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.
The face recognition test is a computerized attention test in which ten unfamiliar faces were presented simultaneously on the computer screen for ten seconds to be remembered. After that, a single face was shown and the patient had to press the button one if he/she remembered or, otherwise, button five. It consisted of a random presentation of ten pre-exposed faces and ten new faces as distracters. The reaction time, assessed per patient, was averaged at each time point for each patient e.g., at baseline, Weeks 8 and 24. This test is part of the Computerized Neuropsychological Test Battery.
Outcome measures
| Measure |
Galantamine + Nimodipine (Baseline)
n=9 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Baseline)
n=12 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 8)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 8)
n=9 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
n=8 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
|---|---|---|---|---|---|---|---|---|
|
Reaction Time for Face Recognition Test at Baseline, Week 8, and Week 24
|
3124.00 milliseconds
Standard Deviation 1461.46
|
2684.45 milliseconds
Standard Deviation 1315.44
|
2262.50 milliseconds
Standard Deviation 803.30
|
2734.25 milliseconds
Standard Deviation 1252.62
|
2357.80 milliseconds
Standard Deviation 1919.72
|
3099.38 milliseconds
Standard Deviation 1823.80
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 8, Week 24Population: Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.
The reaction time for word recognition and learning test is a computerized attention test that evaluates the patient's reaction time. This test is similar to the Face Recognition test procedure using Words. The recognition procedure was repeated three times to evaluate a learning effect. The reaction time, assessed per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24. This test is part of the Computerized Neuropsychological Test Battery (CNTB).
Outcome measures
| Measure |
Galantamine + Nimodipine (Baseline)
n=9 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Baseline)
n=12 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 8)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 8)
n=9 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
n=8 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
|---|---|---|---|---|---|---|---|---|
|
Reaction Time for Word Recognition and Learning Test at Baseline, Week 8, and Week 24
|
2022.17 milliseconds
Standard Deviation 672.08
|
2978.77 milliseconds
Standard Deviation 1867.62
|
1966.40 milliseconds
Standard Deviation 1252.10
|
2379.83 milliseconds
Standard Deviation 984.52
|
1722.00 milliseconds
Standard Deviation 1174.22
|
3038.81 milliseconds
Standard Deviation 1243.79
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 8, Week 24Population: Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.
The Quality of Life assessment scale for caregivers of patients with Alzheimer's disease (QoL-AD) is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). It evaluates the caregivers own perceived quality of life. Total score ranges from 13 to 52. Higher scores represent a better outcome.
Outcome measures
| Measure |
Galantamine + Nimodipine (Baseline)
n=9 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Baseline)
n=12 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 8)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 8)
n=9 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
n=8 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
|---|---|---|---|---|---|---|---|---|
|
The Quality of Life Assessment for Caregivers of Patients With Alzheimer's Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24
|
34.00 scores on a scale
Standard Deviation 6.98
|
36.50 scores on a scale
Standard Deviation 7.40
|
32.00 scores on a scale
Standard Deviation 9.03
|
33.56 scores on a scale
Standard Deviation 6.84
|
36.60 scores on a scale
Standard Deviation 4.56
|
34.88 scores on a scale
Standard Deviation 6.83
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 8, Week 24Population: Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.
The Quality of Life assessment scale for patients with Alzheimer's disease (QoL-AD) is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). Total score ranges from 13 to 52. Higher scores represent a better outcome.
Outcome measures
| Measure |
Galantamine + Nimodipine (Baseline)
n=9 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Baseline)
n=12 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 8)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 8)
n=9 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
n=7 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
|---|---|---|---|---|---|---|---|---|
|
The Quality of Life Assessment for Patients With Alzheimer's Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24
|
33.56 scores on a scale
Standard Deviation 5.59
|
32.67 scores on a scale
Standard Deviation 7.02
|
35.60 scores on a scale
Standard Deviation 3.71
|
33.11 scores on a scale
Standard Deviation 4.68
|
36.60 scores on a scale
Standard Deviation 6.23
|
33.86 scores on a scale
Standard Deviation 5.27
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 8, Week 24Population: Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.
The Quality of Life assessment scale for patients with Alzheimer's disease (QoL-AD), according to the opinion of the caregiver is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). It evaluates the opinion of the caregiver about the patient's quality of life. Total score ranges from 13 to 52. Higher scores represent a better outcome.
Outcome measures
| Measure |
Galantamine + Nimodipine (Baseline)
n=9 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Baseline)
n=12 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 8)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 8)
n=9 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
n=8 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
|---|---|---|---|---|---|---|---|---|
|
The Quality of Life Assessment for Patients With Alzheimer's Disease (QoL- AD) Total Scores, Based on the Caregiver's Opinion, at Baseline, Week 8, Week 24
|
28.33 scores on a scale
Standard Deviation 8.62
|
29.33 scores on a scale
Standard Deviation 8.08
|
27.80 scores on a scale
Standard Deviation 5.36
|
29.78 scores on a scale
Standard Deviation 6.69
|
29.80 scores on a scale
Standard Deviation 5.76
|
29.13 scores on a scale
Standard Deviation 7.00
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8, Week 24Population: Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.
The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation and praxis using an 11-point Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment.
Outcome measures
| Measure |
Galantamine + Nimodipine (Baseline)
n=9 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Baseline)
n=11 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 8)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 8)
n=9 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
n=8 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
|---|---|---|---|---|---|---|---|---|
|
The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) at Baseline, Week 8, and Week 24
|
30.40 scores on a scale
Standard Deviation 13.81
|
28.20 scores on a scale
Standard Deviation 11.06
|
25.10 scores on a scale
Standard Deviation 9.21
|
31.03 scores on a scale
Standard Deviation 11.45
|
25.02 scores on a scale
Standard Deviation 9.75
|
27.70 scores on a scale
Standard Deviation 12.16
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 16, Week 24Population: Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.
The Clinical Global Impression (CGI) is a scale to assess treatment response in patients with mental disorders. The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
Outcome measures
| Measure |
Galantamine + Nimodipine (Baseline)
n=7 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Baseline)
n=10 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 8)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 8)
n=9 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
n=8 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
n=8 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
|---|---|---|---|---|---|---|---|---|
|
The Clinical Global Impression (CGI) at Week 4, Week 8, Week 16, and Week 24
Very much improved
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
The Clinical Global Impression (CGI) at Week 4, Week 8, Week 16, and Week 24
Much improved
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
2 participants
|
|
The Clinical Global Impression (CGI) at Week 4, Week 8, Week 16, and Week 24
Minimally improved
|
1 participants
|
5 participants
|
2 participants
|
6 participants
|
2 participants
|
3 participants
|
3 participants
|
4 participants
|
|
The Clinical Global Impression (CGI) at Week 4, Week 8, Week 16, and Week 24
No change
|
4 participants
|
4 participants
|
2 participants
|
2 participants
|
1 participants
|
5 participants
|
1 participants
|
1 participants
|
|
The Clinical Global Impression (CGI) at Week 4, Week 8, Week 16, and Week 24
Minimally worse
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
The Clinical Global Impression (CGI) at Week 4, Week 8, Week 16, and Week 24
Much worse
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
The Clinical Global Impression (CGI) at Week 4, Week 8, Week 16, and Week 24
Very much worse
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8, Week 24Population: Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.
The NPI evaluates 12 neuropsychiatric domains: delusions, hallucinations, dysphoria, anxiety, aggression, euphoria, dis-inhibition, irritability/lability, apathy, aberrant motor activity, eating disorders, and night-time behavior disturbances. For present domains, the severity and frequency of the behavior are determined. Frequency is rated 1 (rarely) to 4 (very often) and Severity is scored 1 (mild) to 3 (severe). The product scores vary from 1 (mild and rarely) to 12 (very often and severe). Total scores vary from 0 (no present domain) to 144 (all domains are present, are often and severe).
Outcome measures
| Measure |
Galantamine + Nimodipine (Baseline)
n=9 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Baseline)
n=12 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 8)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 8)
n=12 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
n=5 Participants
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
n=8 Participants
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
Galantamine + Nimodipine (Week 24)
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo (Week 24)
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
|---|---|---|---|---|---|---|---|---|
|
The Neuropsychiatric Inventory (NPI) at Baseline, Week 8, and Week 24
|
24.0 scores on a scale
Standard Deviation 14.72
|
26.92 scores on a scale
Standard Deviation 20.66
|
20.20 scores on a scale
Standard Deviation 8.67
|
22.11 scores on a scale
Standard Deviation 17.93
|
15.00 scores on a scale
Standard Deviation 11.55
|
19.75 scores on a scale
Standard Deviation 16.58
|
—
|
—
|
Adverse Events
Galantamine + Nimodipine
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Galantamine + Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Galantamine + Nimodipine
n=9 participants at risk
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo
n=12 participants at risk
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
1/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/9 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
Other adverse events
| Measure |
Galantamine + Nimodipine
n=9 participants at risk
Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
|
Galantamine + Placebo
n=12 participants at risk
Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/9 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/9 • 24 weeks
|
33.3%
4/12 • 24 weeks
|
|
Metabolism and nutrition disorders
Cachexia
|
11.1%
1/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
|
Nervous system disorders
Tinnitus
|
0.00%
0/9 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • 24 weeks
|
16.7%
2/12 • 24 weeks
|
|
Nervous system disorders
Sleepiness
|
0.00%
0/9 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • 24 weeks
|
16.7%
2/12 • 24 weeks
|
|
Nervous system disorders
Vertigo
|
0.00%
0/9 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
|
Gastrointestinal disorders
Gastrointestinal anomaly
|
11.1%
1/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • 24 weeks
|
25.0%
3/12 • 24 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/9 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
|
Gastrointestinal disorders
Dry lips
|
0.00%
0/9 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/9 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • 24 weeks
|
25.0%
3/12 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • 24 weeks
|
25.0%
3/12 • 24 weeks
|
|
Investigations
Blood glucose floating
|
11.1%
1/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
|
Investigations
Loss weight
|
11.1%
1/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
|
Investigations
Murmur
|
11.1%
1/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
|
Infections and infestations
Respiratory airways bacterial infection
|
11.1%
1/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
|
Infections and infestations
Upper respiratory airways viral infection
|
11.1%
1/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
|
Psychiatric disorders
Agitation
|
11.1%
1/9 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
|
Psychiatric disorders
Aggressiveness
|
33.3%
3/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
|
Psychiatric disorders
Visual hallucination
|
11.1%
1/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
|
Psychiatric disorders
Depression
|
11.1%
1/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
|
Psychiatric disorders
Confusional state
|
11.1%
1/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
|
Psychiatric disorders
Impatience
|
0.00%
0/9 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
|
Psychiatric disorders
Irritability
|
0.00%
0/9 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
|
General disorders
Asthenia
|
11.1%
1/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
|
General disorders
Flu symptoms
|
11.1%
1/9 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
|
General disorders
Fatigue
|
11.1%
1/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
|
General disorders
Malaise
|
11.1%
1/9 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
|
General disorders
Nervousness
|
0.00%
0/9 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/9 • 24 weeks
|
8.3%
1/12 • 24 weeks
|
Additional Information
Medical Group Manager
Jan-Cil Brazil
Phone: 55 11 3030-2770
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication and can extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER