Trial Outcomes & Findings for Effects of Galantamine on Cognition (NCT NCT01100775)
NCT ID: NCT01100775
Last Updated: 2022-06-08
Results Overview
Rapid Visual Information Processing (RVIP) measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600milliseconds; the subjects respond when the they see a target sequence of 3 odds or 3 evens in consecutive sequence. Two target sequences are separated by a minimum and maximum of 30 non-target digits.
COMPLETED
PHASE2
12 participants
25 minutes (duration needed to complete this test)
2022-06-08
Participant Flow
Participant milestones
| Measure |
Galantamine, Then Placebo
Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing. Then, after a period of at least one month, participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing.
Galantamine: A lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing.
Placebo: Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing.
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Placebo, Then Galantamine
Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing. Then, after a period of at least one month, participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing.
Galantamine: A lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing.
Placebo: Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing.
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|---|---|---|
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Overall Study
STARTED
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6
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6
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Overall Study
COMPLETED
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6
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6
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Galantamine on Cognition
Baseline characteristics by cohort
| Measure |
All Study Participants
n=12 Participants
All participants that were included in the study
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|---|---|
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Age, Continuous
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53.33 years
STANDARD_DEVIATION 5.96 • n=5 Participants
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Sex: Female, Male
Female
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11 Participants
n=5 Participants
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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8 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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9 Participants
n=5 Participants
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Race (NIH/OMB)
White
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2 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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12 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 25 minutes (duration needed to complete this test)Population: Analyzable data for all participants was not available
Rapid Visual Information Processing (RVIP) measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600milliseconds; the subjects respond when the they see a target sequence of 3 odds or 3 evens in consecutive sequence. Two target sequences are separated by a minimum and maximum of 30 non-target digits.
Outcome measures
| Measure |
Galantamine
n=10 Participants
Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing.
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Placebo
n=9 Participants
Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing.
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|---|---|---|
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RVIP Target Hit and False Alarm (Number of Responses)
RVIP Practice Mean Target Hits
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23.4 Number of responses
Standard Deviation 6.5
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22.8 Number of responses
Standard Deviation 7.47
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RVIP Target Hit and False Alarm (Number of Responses)
RVIP Practice Mean False Alarms
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19.7 Number of responses
Standard Deviation 18.91
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14.88 Number of responses
Standard Deviation 18.12
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RVIP Target Hit and False Alarm (Number of Responses)
RVIP First Half Mean Target Hits
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25.4 Number of responses
Standard Deviation 8.11
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19.75 Number of responses
Standard Deviation 5.42
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RVIP Target Hit and False Alarm (Number of Responses)
RVIP First Half Mean False Alarms
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20.7 Number of responses
Standard Deviation 19.24
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18.88 Number of responses
Standard Deviation 26.49
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PRIMARY outcome
Timeframe: 25 minutes (total duration to test RVIP)Population: Analyzable data for all participants was not available
Rapid Visual Information Processing (RVIP) measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600milliseconds; the subjects respond when the they see a target sequence of 3 odds or 3 evens in consecutive sequence. Two target sequences are separated by a minimum and maximum of 30 non-target digits.
Outcome measures
| Measure |
Galantamine
n=10 Participants
Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing.
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Placebo
n=9 Participants
Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing.
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|---|---|---|
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RVIP Reaction Times (ms)
RVIP Practice Mean Target Reaction Time
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534.2 milliseconds
Standard Deviation 63.3
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581.5 milliseconds
Standard Deviation 82.1
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RVIP Reaction Times (ms)
RVIP Practice Mean False Alarm Reaction Time
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290.5 milliseconds
Standard Deviation 67.5
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380.5 milliseconds
Standard Deviation 75.4
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RVIP Reaction Times (ms)
RVIP First Half Mean Target Reaction Time
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525.1 milliseconds
Standard Deviation 58.7
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544 milliseconds
Standard Deviation 105.6
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RVIP Reaction Times (ms)
RVIP First Half Mean False Alarm Reaction Time
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215 milliseconds
Standard Deviation 129
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260 milliseconds
Standard Deviation 104
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PRIMARY outcome
Timeframe: 20 minutes (total duration of the trust game cognitive test)Population: Analyzable data for all participants was not available
Participants compete in a social trust game in which they are paired with a partner (the computer program). Over the course of 24 rounds he participant can offer up to $10 to their partner. The partner can either accept the offer, in which case the total amount offered is split equally between the participant and their partner (i.e. $10 is split into $5 each). Or the partner can reject the offer and receive a portion of the toal offer for themselves and give the participant nothing ($0). The total amount of money that can be offered ranges from $0-240.
Outcome measures
| Measure |
Galantamine
n=10 Participants
Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing.
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Placebo
n=9 Participants
Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing.
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|---|---|---|
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Trust Game (Dollar Amount Earned)
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147.7 Dollars
Standard Deviation 81.1
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131.4 Dollars
Standard Deviation 42.3
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PRIMARY outcome
Timeframe: 5 minutes (duration needed to complete the assessment)Population: Analyzable data for all participants was not available
The BACS Symbol Coding subtest will be used to assess processing speed, and the demographically corrected T score, will be used for data analysis. This test requires less than 5 minutes to administer adn provides a highly reliable measure of processing speed. There are nine symbols coded 1 through 9. Participants are given 90 seconds to match a series of these symbols with their corresponding number. The total correct matches in the participants score. Scores range from 0-110.
Outcome measures
| Measure |
Galantamine
n=10 Participants
Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing.
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Placebo
n=9 Participants
Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing.
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|---|---|---|
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Brief Assessment of Cognition for Schizophrenia (BACS) Score
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49 Number of correct responses
Standard Deviation 9.82
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52 Number of correct responses
Standard Deviation 8
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PRIMARY outcome
Timeframe: 15 minutes (duration needed to complete this test)Population: Analyzable data for all participants was not available
HVLT comes in 6 different forms. Forms 4 and 5 were used for this study with one form administered on the first day and the other on the second and were counterbalanced between subjects. Each form contains 12 nouns, four words each from one of three semantic categories, to be learned over the course of three learning trials.
Outcome measures
| Measure |
Galantamine
n=10 Participants
Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing.
|
Placebo
n=9 Participants
Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing.
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|---|---|---|
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Hopkins Verbal Learning Test (HVLT) Score
HVLT Trial 2
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9.7 Number of correct responses
Standard Deviation 1.77
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10.22 Number of correct responses
Standard Deviation 1.48
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Hopkins Verbal Learning Test (HVLT) Score
HVLT Trial 1
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7.7 Number of correct responses
Standard Deviation 2.26
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7.22 Number of correct responses
Standard Deviation 1.99
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Hopkins Verbal Learning Test (HVLT) Score
HVLT Trial 3
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10.8 Number of correct responses
Standard Deviation 1.55
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10.78 Number of correct responses
Standard Deviation 1.3
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PRIMARY outcome
Timeframe: 10 minutes (duration needed to complete the test)Population: Analyzable data was not available for all participants
A 30 item task presents a picture of a person's eyes and the participant is asked to determine the person's mental state from 4 multiple choice options.
Outcome measures
| Measure |
Galantamine
n=10 Participants
Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing.
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Placebo
n=9 Participants
Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing.
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Reading the Mind in the Eyes Score (Number of Correct Responses)
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24.9 Number of correct responses
Standard Deviation 5.26
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24.12 Number of correct responses
Standard Deviation 3.98
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PRIMARY outcome
Timeframe: 5 minutes (duration usually needed to complete this test)Population: analyzable data for all participant was not available
The Brief Smell Identification Test (B-SIT) is a 5-minute, 12-item screening test. Participants try to identify 12 different odors with four multiple choice options given for each odor.
Outcome measures
| Measure |
Galantamine
n=10 Participants
Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing.
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Placebo
n=9 Participants
Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing.
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|---|---|---|
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The Brief Smell Identification Test (B-SIT) Score (Number of Correct Responses)
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10.2 Number of correct responses
Standard Deviation 1.476
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10.222 Number of correct responses
Standard Deviation 0.833
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SECONDARY outcome
Timeframe: 30 minutes (time needed to complete this test)Population: analyzable data was not available for all participants
In a videotaped session, research staff engages the participant in social interaction based on a role play. The tape is rated on social skills and on Positive and Negative Affect Scale. participants are rated on a 5 point likert scale ranging from very poor (1) to very good (5)
Outcome measures
| Measure |
Galantamine
n=10 Participants
Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing.
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Placebo
n=10 Participants
Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing.
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|---|---|---|
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Social Affiliation Measured by Social Affiliative Role Play (Rating Scale Score)
Overall Affect
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3.958 units on a scale
Standard Deviation 0.68
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3.8 units on a scale
Standard Deviation 0.632
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Social Affiliation Measured by Social Affiliative Role Play (Rating Scale Score)
Overall Social Skill
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4.15 units on a scale
Standard Deviation 0.58
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3.8 units on a scale
Standard Deviation 0.715
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SECONDARY outcome
Timeframe: 10 minutes (time usually needed to complete this test)Population: analyzable data was not available for all participants
This computer administered test includes 40 color photogralhs of four emotions (happy, sad, angry, and fearful) balanced for the posers gender, age and ethnicity, including four low intensity and four high intensity facila expressions of each emotion, plus 8 neutral faces. The stimuli are presented in random order and subjects are asked to identify which stimuli were presented to them at the end. Performance on this test correlates with negative symptom severity
Outcome measures
| Measure |
Galantamine
n=10 Participants
Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing.
|
Placebo
n=9 Participants
Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing.
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|---|---|---|
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Facial Affect Recognition Score (Number of Responses)
Facial Affect Total
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31.2 Number of Responses
Standard Deviation 4.49
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33 Number of Responses
Standard Deviation 5.21
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Facial Affect Recognition Score (Number of Responses)
Facial Affect Hits
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12.3 Number of Responses
Standard Deviation 7.07
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14.38 Number of Responses
Standard Deviation 4.75
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Facial Affect Recognition Score (Number of Responses)
Facial Affect False Alarms
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5.1 Number of Responses
Standard Deviation 4.46
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5.38 Number of Responses
Standard Deviation 3.07
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Adverse Events
Galantamine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Galantamine
n=12 participants at risk
Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing.
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Placebo
n=12 participants at risk
Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing.
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|---|---|---|
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General disorders
Dizziness
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16.7%
2/12 • Number of events 2 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
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0.00%
0/12 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
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General disorders
Euphoria
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8.3%
1/12 • Number of events 1 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
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0.00%
0/12 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
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General disorders
Drowsiness
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8.3%
1/12 • Number of events 1 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
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0.00%
0/12 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
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General disorders
Blurred Vision
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8.3%
1/12 • Number of events 1 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
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0.00%
0/12 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
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General disorders
Tearing of Eyes
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8.3%
1/12 • Number of events 1 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
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0.00%
0/12 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
|
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General disorders
Insomnia
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16.7%
2/12 • Number of events 2 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
|
0.00%
0/12 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
|
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General disorders
Nausea
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16.7%
2/12 • Number of events 2 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
|
0.00%
0/12 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
|
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General disorders
Headache
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8.3%
1/12 • Number of events 1 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
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8.3%
1/12 • Number of events 1 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
|
|
General disorders
Malaise
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8.3%
1/12 • Number of events 1 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
|
0.00%
0/12 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
|
|
General disorders
Sedation
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8.3%
1/12 • Number of events 1 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
|
0.00%
0/12 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
|
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General disorders
Dry mouth
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8.3%
1/12 • Number of events 1 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
|
0.00%
0/12 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
|
|
General disorders
Abdominal Pain
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8.3%
1/12 • Number of events 1 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
|
0.00%
0/12 • Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place