Trial Outcomes & Findings for Central Nervous System Effects Following Infusion of Diphenhydramine Using Pharmacokinetic and Pharmacodynamic Modeling (NCT NCT05219604)
NCT ID: NCT05219604
Last Updated: 2026-01-22
Results Overview
Change in the results of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation after diphenhydramine administration compared to baseline. Reaction Time Median Five-Choice Reaction Time is the median duration it took for a subject to release the response button after the presentation of the target stimulus, calculated across correct, assessed trials in which the stimulus could appear in any one of five locations. Lower is better. Minimum score is 100 and maximum score is 5100.
TERMINATED
PHASE4
3 participants
Change from before to after diphenhydramine administration (30, 60, 210, 240, 450, and 480 minutes after diphenhydramine)
2026-01-22
Participant Flow
Participant milestones
| Measure |
Diphenhydramine 50 mg IV Infusion
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Central Nervous System Effects Following Infusion of Diphenhydramine Using Pharmacokinetic and Pharmacodynamic Modeling
Baseline characteristics by cohort
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=270 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=270 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=270 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=270 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=270 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=270 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=270 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=270 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=270 Participants
|
PRIMARY outcome
Timeframe: Change from before to after diphenhydramine administration (30, 60, 210, 240, 450, and 480 minutes after diphenhydramine)Population: Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.
Change in the results of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation after diphenhydramine administration compared to baseline. Reaction Time Median Five-Choice Reaction Time is the median duration it took for a subject to release the response button after the presentation of the target stimulus, calculated across correct, assessed trials in which the stimulus could appear in any one of five locations. Lower is better. Minimum score is 100 and maximum score is 5100.
Outcome measures
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Change in Score of Battery of Cognitive Function Tests (Reaction Time)
Reaction Time 30 Minutes Post-Diphenhydramine (Median Five-Choice Movement Time)
|
289.7 ms
Standard Deviation 87.8
|
|
Change in Score of Battery of Cognitive Function Tests (Reaction Time)
Reaction Time Pre-Diphenhydramine (Median Five-Choice Movement Time)
|
246 ms
Standard Deviation 51.4
|
|
Change in Score of Battery of Cognitive Function Tests (Reaction Time)
Reaction Time 210 Minutes Post-Diphenhydramine (Median Five-Choice Movement Time)
|
267.0 ms
Standard Deviation 72.9
|
|
Change in Score of Battery of Cognitive Function Tests (Reaction Time)
Reaction Time 450 Minutes Post-Diphenhydramine (Median Five-Choice Movement Time)
|
292.8 ms
Standard Deviation 94.6
|
PRIMARY outcome
Timeframe: Change from before to after diphenhydramine administration (30, 60, 210, 240, 450, and 480 minutes after diphenhydramine)Population: Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.
Change in the results of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation after diphenhydramine administration compared to baseline. Digit Span Maximum Span Passed Forwards is the longest sequence problem successfully reached and passed by the subject. Higher is better. Minimum score is 0 and maximum score is 9.
Outcome measures
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Change in Score of Battery of Cognitive Function Tests (Digit Span)
Digit Span 210 Minutes Post-Diphenhydramine (Maximum Span Passed Forwards)
|
6.3 units on a scale
Standard Deviation 1.2
|
|
Change in Score of Battery of Cognitive Function Tests (Digit Span)
Digit Span Pre-Diphenhydramine (Maximum Span Passed Forwards)
|
5 units on a scale
Standard Deviation 1.0
|
|
Change in Score of Battery of Cognitive Function Tests (Digit Span)
Digit Span 30 Minutes Post-Diphenhydramine (Maximum Span Passed Forwards)
|
5.3 units on a scale
Standard Deviation 1.5
|
|
Change in Score of Battery of Cognitive Function Tests (Digit Span)
Digit Span 450 Minutes Post-Diphenhydramine (Maximum Span Passed Forwards)
|
5.7 units on a scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: Change from before to after diphenhydramine administration (30, 60, 210, 240, 450, and 480 minutes after diphenhydramine)Population: Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.
Change in the results of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation after diphenhydramine administration compared to baseline. The Visual Analog Scale for Sedation is a scale where participants indicate their current state on a scale from "Sedated" to "Alert". Higher score is more alert. Minimum score is 0 and maximum score is 12.8.
Outcome measures
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Change in Score of Battery of Cognitive Function Tests (Visual Analog Scale for Sedation)
Visual Analog Scale for Sedation Pre-Diphenhydramine
|
12.3 units on a scale
Standard Deviation 0.4
|
|
Change in Score of Battery of Cognitive Function Tests (Visual Analog Scale for Sedation)
Visual Analog Scale for Sedation 30 Minutes Post-Diphenhydramine
|
4.9 units on a scale
Standard Deviation 5.3
|
|
Change in Score of Battery of Cognitive Function Tests (Visual Analog Scale for Sedation)
Visual Analog Scale for Sedation 210 Minutes Post-Diphenhydramine
|
7.9 units on a scale
Standard Deviation 3.7
|
|
Change in Score of Battery of Cognitive Function Tests (Visual Analog Scale for Sedation)
Visual Analog Scale for Sedation 450 Minutes Post-Diphenhydramine
|
6.9 units on a scale
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: Change from before to after diphenhydramine administration (30, 60, 210, 240, 450, and 480 minutes after diphenhydramine)Population: Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.
Change in the results of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation after diphenhydramine administration compared to baseline. Spatial Working Memory Between Errors is the number of times the subject incorrectly revisits a box in which a token has been previously found. Lower is better. Minimum score is 0 and maximum score is 63.
Outcome measures
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Change in Score of Battery of Cognitive Function Tests (Spatial Working Memory)
Spatial Working Memory Pre-Diphenhydramine (Between Errors)
|
1.7 units on a scale
Standard Deviation 2.9
|
|
Change in Score of Battery of Cognitive Function Tests (Spatial Working Memory)
Spatial Working Memory 30 Minutes Post-Diphenhydramine (Between Errors)
|
4.0 units on a scale
Standard Deviation 6.9
|
|
Change in Score of Battery of Cognitive Function Tests (Spatial Working Memory)
Spatial Working Memory 210 Minutes Post-Diphenhydramine (Between Errors)
|
1.0 units on a scale
Standard Deviation 1.7
|
|
Change in Score of Battery of Cognitive Function Tests (Spatial Working Memory)
Spatial Working Memory 450 Minutes Post-Diphenhydramine (Between Errors)
|
2.3 units on a scale
Standard Deviation 4.0
|
PRIMARY outcome
Timeframe: Change from before to after diphenhydramine administration (30, 60, 210, 240, 450, and 480 minutes after diphenhydramine)Population: Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.
Change in the results of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation after diphenhydramine administration compared to baseline. Paired Associates Learning First Attempt Memory Score is the number of times a subject chose the correct box on their first attempt when recalling the pattern locations. Higher is better. Minimum score is 0 and maximum score is 20.
Outcome measures
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Change in Score of Battery of Cognitive Function Tests (Paired Associates Learning)
Paired Associates Learning Pre-Diphenhydramine (First Attempt Memory Score)
|
16.0 units on a scale
Standard Deviation 3.6
|
|
Change in Score of Battery of Cognitive Function Tests (Paired Associates Learning)
Paired Associates Learning 30 Minutes Post-Diphenhydramine (First Attempt Memory Score)
|
11.7 units on a scale
Standard Deviation 6.1
|
|
Change in Score of Battery of Cognitive Function Tests (Paired Associates Learning)
Paired Associates Learning 210 Minutes Post-Diphenhydramine (First Attempt Memory Score)
|
15.7 units on a scale
Standard Deviation 4.0
|
|
Change in Score of Battery of Cognitive Function Tests (Paired Associates Learning)
Paired Associates Learning 450 Minutes Post-Diphenhydramine (First Attempt Memory Score)
|
14.0 units on a scale
Standard Deviation 4.6
|
PRIMARY outcome
Timeframe: Change from before to after diphenhydramine administration (30, 60, 210, 240, 450, and 480 minutes after diphenhydramine)Population: Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.
Change in the results of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation after diphenhydramine administration compared to baseline. Rapid Visual Processing Median Response Latency is the median response latency on trials where the subject responded correctly, calculated across all assessed trials. Lower is better. Minimum score is 0 and maximum score is 908.
Outcome measures
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Change in Score of Battery of Cognitive Function Tests (Rapid Visual Information Processing)
Rapid Visual Information Processing Pre-Diphenhydramine (Median Response Latency)
|
482.3 units on a scale
Standard Deviation 16.5
|
|
Change in Score of Battery of Cognitive Function Tests (Rapid Visual Information Processing)
Rapid Visual Information Processing 30 Minutes Post-Diphenhydramine (Median Response Latency)
|
532.2 units on a scale
Standard Deviation 50.3
|
|
Change in Score of Battery of Cognitive Function Tests (Rapid Visual Information Processing)
Rapid Visual Information Processing 210 Minutes Post-Diphenhydramine (Median Response Latency)
|
504.7 units on a scale
Standard Deviation 37.5
|
|
Change in Score of Battery of Cognitive Function Tests (Rapid Visual Information Processing)
Rapid Visual Information Processing 450 Minutes Post-Diphenhydramine (Median Response Latency)
|
471.8 units on a scale
Standard Deviation 41.3
|
SECONDARY outcome
Timeframe: Before and after diphenhydramine administration (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration)Population: Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.
Score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (0, 30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration). Reaction Time Median Five-Choice Reaction Time is the median duration it took for a subject to release the response button after the presentation of the target stimulus, calculated across correct, assessed trials in which the stimulus could appear in any one of five locations. Lower is better. Minimum score is 100 and maximum score is 5100.
Outcome measures
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Reaction Time)
Elderly Reaction Time Pre-Diphenhydramine (Median Five-Choice Movement Time)
|
264 ms
Standard Deviation 58.3
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Reaction Time)
Adult Reaction Time Pre-Diphenhydramine (Median Five-Choice Movement Time)
|
211 ms
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Reaction Time)
Elderly Reaction Time 30 Minutes Post-Diphenhydramine (Median Five-Choice Movement Time)
|
314.0 ms
Standard Deviation 108.9
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Reaction Time)
Adult Reaction Time 30 Minutes Post-Diphenhydramine (Median Five-Choice Movement Time)
|
241.0 ms
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Reaction Time)
Elderly Reaction Time 210 Minutes Post-Diphenhydramine (Median Five-Choice Movement Time)
|
278.3 ms
Standard Deviation 99.3
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Reaction Time)
Adult Reaction Time 210 Minutes Post-Diphenhydramine (Median Five-Choice Movement Time)
|
244.5 ms
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Reaction Time)
Elderly Reaction Time 450 Minutes Post-Diphenhydramine (Median Five-Choice Movement Time)
|
321.0 ms
Standard Deviation 114.6
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Reaction Time)
Adult Reaction Time 450 Minutes Post-Diphenhydramine (Median Five-Choice Movement Time)
|
236.5 ms
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
SECONDARY outcome
Timeframe: Before and after diphenhydramine administration (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration)Population: Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.
Score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (0, 30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration). Digit Span Maximum Span Passed Forwards is the longest sequence problem successfully reached and passed by the subject. Higher is better. Minimum score is 0 and maximum score is 9.
Outcome measures
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Digit Span)
Elderly Digit Span Pre-Diphenhydramine (Maximum Span Passed Forwards)
|
5.0 units on a scale
Standard Deviation 1.4
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Digit Span)
Adult Digit Span Pre-Diphenhydramine (Maximum Span Passed Forwards)
|
5.0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Digit Span)
Elderly Digit Span 30 Minutes Post-Diphenhydramine (Maximum Span Passed Forwards)
|
5.5 units on a scale
Standard Deviation 2.1
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Digit Span)
Adult Digit Span 30 Minutes Post-Diphenhydramine (Maximum Span Passed Forwards)
|
5.0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Digit Span)
Elderly Digit Span 210 Minutes Post-Diphenhydramine (Maximum Span Passed Forwards)
|
6.0 units on a scale
Standard Deviation 1.4
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Digit Span)
Adult Digit Span 210 Minutes Post-Diphenhydramine (Maximum Span Passed Forwards)
|
7.0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Digit Span)
Elderly Digit Span 450 Minutes Post-Diphenhydramine (Maximum Span Passed Forwards)
|
6.0 units on a scale
Standard Deviation 1.4
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Digit Span)
Adult Digit Span 450 Minutes Post-Diphenhydramine (Maximum Span Passed Forwards)
|
5.0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
SECONDARY outcome
Timeframe: Before and after diphenhydramine administration (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration)Population: Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.
Score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (0, 30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration). The Visual Analog Scale for Sedation is a scale where participants indicate their current state on a scale from "Sedated" to "Alert". Higher score is more alert. Minimum score is 0 and maximum score is 12.8.
Outcome measures
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Visual Analog Scale for Sedation)
Elderly Visual Analog Scale for Sedation Pre-Diphenhydramine
|
12.3 units on a scale
Standard Deviation 0.5
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Visual Analog Scale for Sedation)
Adult Visual Analog Scale for Sedation Pre-Diphenhydramine
|
12.3 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Visual Analog Scale for Sedation)
Elderly Visual Analog Scale for Sedation 30 Minutes Post-Diphenhydramine
|
2.0 units on a scale
Standard Deviation 2.2
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Visual Analog Scale for Sedation)
Adult Visual Analog Scale for Sedation 30 Minutes Post-Diphenhydramine
|
10.8 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Visual Analog Scale for Sedation)
Elderly Visual Analog Scale for Sedation 210 Minutes Post-Diphenhydramine
|
6.3 units on a scale
Standard Deviation 3.2
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Visual Analog Scale for Sedation)
Adult Visual Analog Scale for Sedation 210 Minutes Post-Diphenhydramine
|
11.3 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Visual Analog Scale for Sedation)
Elderly Visual Analog Scale for Sedation 450 Minutes Post-Diphenhydramine
|
4.8 units on a scale
Standard Deviation 6.4
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Visual Analog Scale for Sedation)
Adult Visual Analog Scale for Sedation 450 Minutes Post-Diphenhydramine
|
11.3 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
SECONDARY outcome
Timeframe: Before and after diphenhydramine administration (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration)Population: Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.
Score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (0, 30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration). Spatial Working Memory Between Errors is the number of times the subject incorrectly revisits a box in which a token has been previously found. Lower is better. Minimum score is 0 and maximum score is 63.
Outcome measures
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Spatial Working Memory)
Elderly Spatial Working Memory Pre-Diphenhydramine (Between Errors)
|
2.5 units on a scale
Standard Deviation 3.5
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Spatial Working Memory)
Adult Spatial Working Memory Pre-Diphenhydramine (Between Errors)
|
0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Spatial Working Memory)
Elderly Spatial Working Memory 30 Minutes Post-Diphenhydramine (Between Errors)
|
6.0 units on a scale
Standard Deviation 8.5
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Spatial Working Memory)
Adult Spatial Working Memory 30 Minutes Post-Diphenhydramine (Between Errors)
|
0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Spatial Working Memory)
Elderly Spatial Working Memory 210 Minutes Post-Diphenhydramine (Between Errors)
|
0 units on a scale
Standard Deviation 0
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Spatial Working Memory)
Adult Spatial Working Memory 210 Minutes Post-Diphenhydramine (Between Errors)
|
3 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Spatial Working Memory)
Elderly Spatial Working Memory 450 Minutes Post-Diphenhydramine (Between Errors)
|
3.5 units on a scale
Standard Deviation 4.9
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Spatial Working Memory)
Adult Spatial Working Memory 450 Minutes Post-Diphenhydramine (Between Errors)
|
0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
SECONDARY outcome
Timeframe: Before and after diphenhydramine administration (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration)Population: Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.
Score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (0, 30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration). Paired Associates Learning First Attempt Memory Score is the number of times a subject chose the correct box on their first attempt when recalling the pattern locations. Higher is better. Minimum score is 0 and maximum score is 20.
Outcome measures
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Paired Associates Learning)
Elderly Paired Associates Learning Pre-Diphenhydramine (First Attempt Memory Score)
|
18.0 units on a scale
Standard Deviation 1.4
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Paired Associates Learning)
Adult Paired Associates Learning Pre-Diphenhydramine (First Attempt Memory Score)
|
12.0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Paired Associates Learning)
Elderly Paired Associates Learning 30 Minutes Post-Diphenhydramine (First Attempt Memory Score)
|
11.0 units on a scale
Standard Deviation 8.5
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Paired Associates Learning)
Adult Paired Associates Learning 30 Minutes Post-Diphenhydramine (First Attempt Memory Score)
|
13.0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Paired Associates Learning)
Elderly Paired Associates Learning 210 Minutes Post-Diphenhydramine (First Attempt Memory Score)
|
14.5 units on a scale
Standard Deviation 4.9
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Paired Associates Learning)
Adult Paired Associates Learning 210 Minutes Post-Diphenhydramine (First Attempt Memory Score)
|
18.0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Paired Associates Learning)
Elderly Paired Associates Learning 450 Minutes Post-Diphenhydramine (First Attempt Memory Score)
|
14.5 units on a scale
Standard Deviation 6.4
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Paired Associates Learning)
Adult Paired Associates Learning 450 Minutes Post-Diphenhydramine (First Attempt Memory Score)
|
13.0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
SECONDARY outcome
Timeframe: Before and after diphenhydramine administration (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration)Population: Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.
Score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (0, 30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration). Rapid Visual Processing Median Response Latency is the median response latency on trials where the subject responded correctly, calculated across all assessed trials. Lower is better. Minimum score is 0 and maximum score is 908.
Outcome measures
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Rapid Visual Information Processing)
Elderly Rapid Visual Information Processing Pre-Diphenhydramine (Median Response Latency)
|
490.5 units on a scale
Standard Deviation 12.0
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Rapid Visual Information Processing)
Adult Rapid Visual Information Processing Pre-Diphenhydramine (Median Response Latency)
|
466 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Rapid Visual Information Processing)
Elderly Rapid Visual Information Processing 30 Min Post-Diphenhydramine (Median Response Latency)
|
532.3 units on a scale
Standard Deviation 71.1
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Rapid Visual Information Processing)
Adult Rapid Visual Information Processing 30 Min Post-Diphenhydramine (Median Response Latency)
|
532 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Rapid Visual Information Processing)
Elderly Rapid Visual Information Processing 210 Min Post-Diphenhydramine (Median Response Latency)
|
516.0 units on a scale
Standard Deviation 45.3
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Rapid Visual Information Processing)
Adult Rapid Visual Information Processing 210 Min Post-Diphenhydramine (Median Response Latency)
|
482 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Rapid Visual Information Processing)
Elderly Rapid Visual Information Processing 450 Min Post-Diphenhydramine (Median Response Latency)
|
472.8 units on a scale
Standard Deviation 58.3
|
|
Elderly vs. Adult Score of Battery of Cognitive Function Tests at Specified Time Points (Rapid Visual Information Processing)
Adult Rapid Visual Information Processing 450 Min Post-Diphenhydramine (Median Response Latency)
|
470 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
SECONDARY outcome
Timeframe: Immediately after diphenhydramine administration to 480 minutes after diphenhydramine administrationPopulation: Blood was collected from study participants as specified in the study protocol; however, samples were destroyed and not analyzed due to early study termination. Therefore, there are no results for this endpoint to report.
Difference between diphenhydramine pharmacokinetic area under the curve (AUC) in elderly subjects aged 65+ vs. adult subjects aged 35 to 50
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from before to after diphenhydramine administration (30, 60, 210, 240, 450, and 480 minutes after diphenhydramine)Population: Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.
Change in the score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration) compared to baseline. Reaction Time Median Five-Choice Reaction Time is the median duration it took for a subject to release the response button after the presentation of the target stimulus, calculated across correct, assessed trials in which the stimulus could appear in any one of five locations. Lower is better. Minimum score is 100 and maximum score is 5100.
Outcome measures
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Reaction Time)
Elderly Reaction Time Pre-Diphenhydramine (Median Five-Choice Movement Time)
|
264 ms
Standard Deviation 58.3
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Reaction Time)
Adult Reaction Time Pre-Diphenhydramine (Median Five-Choice Movement Time)
|
211 ms
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Reaction Time)
Elderly Reaction Time 30 Minutes Post-Diphenhydramine (Median Five-Choice Movement Time)
|
314.0 ms
Standard Deviation 108.9
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Reaction Time)
Adult Reaction Time 30 Minutes Post-Diphenhydramine (Median Five-Choice Movement Time)
|
241.0 ms
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Reaction Time)
Elderly Reaction Time 210 Minutes Post-Diphenhydramine (Median Five-Choice Movement Time)
|
278.3 ms
Standard Deviation 99.3
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Reaction Time)
Adult Reaction Time 210 Minutes Post-Diphenhydramine (Median Five-Choice Movement Time)
|
244.5 ms
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Reaction Time)
Elderly Reaction Time 450 Minutes Post-Diphenhydramine (Median Five-Choice Movement Time)
|
321.0 ms
Standard Deviation 114.6
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Reaction Time)
Adult Reaction Time 450 Minutes Post-Diphenhydramine (Median Five-Choice Movement Time)
|
236.5 ms
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
SECONDARY outcome
Timeframe: Change from before to after diphenhydramine administration (30, 60, 210, 240, 450, and 480 minutes after diphenhydramine)Population: Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.
Change in the score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration) compared to baseline. Digit Span Maximum Span Passed Forwards is the longest sequence problem successfully reached and passed by the subject. Higher is better. Minimum score is 0 and maximum score is 9.
Outcome measures
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Digit Span)
Elderly Digit Span Pre-Diphenhydramine (Maximum Span Passed Forwards)
|
5.0 units on a scale
Standard Deviation 1.4
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Digit Span)
Elderly Digit Span 210 Minutes Post-Diphenhydramine (Maximum Span Passed Forwards)
|
6.0 units on a scale
Standard Deviation 1.4
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Digit Span)
Adult Digit Span Pre-Diphenhydramine (Maximum Span Passed Forwards)
|
5.0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Digit Span)
Elderly Digit Span 30 Minutes Post-Diphenhydramine (Maximum Span Passed Forwards)
|
5.5 units on a scale
Standard Deviation 2.1
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Digit Span)
Adult Digit Span 30 Minutes Post-Diphenhydramine (Maximum Span Passed Forwards)
|
5.0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Digit Span)
Adult Digit Span 210 Minutes Post-Diphenhydramine (Maximum Span Passed Forwards)
|
7.0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Digit Span)
Elderly Digit Span 450 Minutes Post-Diphenhydramine (Maximum Span Passed Forwards)
|
6.0 units on a scale
Standard Deviation 1.4
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Digit Span)
Adult Digit Span 450 Minutes Post-Diphenhydramine (Maximum Span Passed Forwards)
|
5.0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
SECONDARY outcome
Timeframe: Change from before to after diphenhydramine administration (30, 60, 210, 240, 450, and 480 minutes after diphenhydramine)Population: Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.
Change in the score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration) compared to baseline. The Visual Analog Scale for Sedation is a scale where participants indicate their current state on a scale from "Sedated" to "Alert". Higher score is more alert. Minimum score is 0 and maximum score is 12.8.
Outcome measures
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Visual Analog Scale for Sedation)
Elderly Visual Analog Scale for Sedation Pre-Diphenhydramine
|
12.3 units on a scale
Standard Deviation 0.5
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Visual Analog Scale for Sedation)
Adult Visual Analog Scale for Sedation Pre-Diphenhydramine
|
12.3 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Visual Analog Scale for Sedation)
Elderly Visual Analog Scale for Sedation 30 Minutes Post-Diphenhydramine
|
2.0 units on a scale
Standard Deviation 2.2
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Visual Analog Scale for Sedation)
Adult Visual Analog Scale for Sedation 30 Minutes Post-Diphenhydramine
|
10.8 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Visual Analog Scale for Sedation)
Elderly Visual Analog Scale for Sedation 210 Minutes Post-Diphenhydramine
|
6.3 units on a scale
Standard Deviation 3.2
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Visual Analog Scale for Sedation)
Adult Visual Analog Scale for Sedation 210 Minutes Post-Diphenhydramine
|
11.3 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Visual Analog Scale for Sedation)
Elderly Visual Analog Scale for Sedation 450 Minutes Post-Diphenhydramine
|
4.8 units on a scale
Standard Deviation 6.4
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Visual Analog Scale for Sedation)
Adult Visual Analog Scale for Sedation 450 Minutes Post-Diphenhydramine
|
11.3 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
SECONDARY outcome
Timeframe: Change from before to after diphenhydramine administration (30, 60, 210, 240, 450, and 480 minutes after diphenhydramine)Population: Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.
Change in the score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration) compared to baseline. Spatial Working Memory Between Errors is the number of times the subject incorrectly revisits a box in which a token has been previously found. Lower is better. Minimum score is 0 and maximum score is 63.
Outcome measures
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Spatial Working Memory)
Elderly Spatial Working Memory Pre-Diphenhydramine (Between Errors)
|
2.5 units on a scale
Standard Deviation 3.5
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Spatial Working Memory)
Adult Spatial Working Memory Pre-Diphenhydramine (Between Errors)
|
0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Spatial Working Memory)
Elderly Spatial Working Memory 30 Minutes Post-Diphenhydramine (Between Errors)
|
6.0 units on a scale
Standard Deviation 8.5
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Spatial Working Memory)
Adult Spatial Working Memory 30 Minutes Post-Diphenhydramine (Between Errors)
|
0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Spatial Working Memory)
Elderly Spatial Working Memory 210 Minutes Post-Diphenhydramine (Between Errors)
|
0 units on a scale
Standard Deviation 0
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Spatial Working Memory)
Adult Spatial Working Memory 210 Minutes Post-Diphenhydramine (Between Errors)
|
3 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Spatial Working Memory)
Elderly Spatial Working Memory 450 Minutes Post-Diphenhydramine (Between Errors)
|
3.5 units on a scale
Standard Deviation 4.9
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Spatial Working Memory)
Adult Spatial Working Memory 450 Minutes Post-Diphenhydramine (Between Errors)
|
0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
SECONDARY outcome
Timeframe: Change from before to after diphenhydramine administration (30, 60, 210, 240, 450, and 480 minutes after diphenhydramine)Population: Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.
Change in the score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration) compared to baseline. Paired Associates Learning First Attempt Memory Score is the number of times a subject chose the correct box on their first attempt when recalling the pattern locations. Higher is better. Minimum score is 0 and maximum score is 20.
Outcome measures
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Paired Associates Learning)
Elderly Paired Associates Learning Pre-Diphenhydramine (First Attempt Memory Score)
|
18.0 units on a scale
Standard Deviation 1.4
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Paired Associates Learning)
Adult Paired Associates Learning Pre-Diphenhydramine (First Attempt Memory Score)
|
12.0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Paired Associates Learning)
Elderly Paired Associates Learning 30 Minutes Post-Diphenhydramine (First Attempt Memory Score)
|
11.0 units on a scale
Standard Deviation 8.5
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Paired Associates Learning)
Adult Paired Associates Learning 30 Minutes Post-Diphenhydramine (First Attempt Memory Score)
|
13.0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Paired Associates Learning)
Elderly Paired Associates Learning 210 Minutes Post-Diphenhydramine (First Attempt Memory Score)
|
14.5 units on a scale
Standard Deviation 4.9
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Paired Associates Learning)
Adult Paired Associates Learning 210 Minutes Post-Diphenhydramine (First Attempt Memory Score)
|
18.0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Paired Associates Learning)
Elderly Paired Associates Learning 450 Minutes Post-Diphenhydramine (First Attempt Memory Score)
|
14.5 units on a scale
Standard Deviation 6.4
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Paired Associates Learning)
Adult Paired Associates Learning 450 Minutes Post-Diphenhydramine (First Attempt Memory Score)
|
13.0 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
SECONDARY outcome
Timeframe: Change from before to after diphenhydramine administration (30, 60, 210, 240, 450, and 480 minutes after diphenhydramine)Population: Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.
Change in the score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration) compared to baseline. Rapid Visual Processing Median Response Latency is the median response latency on trials where the subject responded correctly, calculated across all assessed trials. Lower is better. Minimum score is 0 and maximum score is 908.
Outcome measures
| Measure |
Diphenhydramine 50 mg IV Infusion
n=3 Participants
Participants received an IV infusion containing 50 mg diphenhydramine in NS.
|
|---|---|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Rapid Visual Information Processing)
Elderly Rapid Visual Information Processing Pre-Diphenhydramine (Median Response Latency)
|
490.5 units on a scale
Standard Deviation 12.0
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Rapid Visual Information Processing)
Adult Rapid Visual Information Processing Pre-Diphenhydramine (Median Response Latency)
|
466 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Rapid Visual Information Processing)
Elderly Rapid Visual Information Processing 30 Min Post-Diphenhydramine (Median Response Latency)
|
532.3 units on a scale
Standard Deviation 71.1
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Rapid Visual Information Processing)
Adult Rapid Visual Information Processing 30 Min Post-Diphenhydramine (Median Response Latency)
|
532 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Rapid Visual Information Processing)
Elderly Rapid Visual Information Processing 210 Min Post-Diphenhydramine (Median Response Latency)
|
516.0 units on a scale
Standard Deviation 45.3
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Rapid Visual Information Processing)
Adult Rapid Visual Information Processing 210 Min Post-Diphenhydramine (Median Response Latency)
|
482 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
|
|
Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Rapid Visual Information Processing)
Elderly Rapid Visual Information Processing 450 Min Post-Diphenhydramine (Median Response Latency)
|
472.8 units on a scale
Standard Deviation 58.3
|
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Elderly vs. Adult Change in Score of Battery of Cognitive Function Tests After Diphenhydramine (Rapid Visual Information Processing)
Adult Rapid Visual Information Processing 450 Min Post-Diphenhydramine (Median Response Latency)
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470 units on a scale
Standard Deviation NA
Data from 1 subject are available; therefore, standard deviation is not applicable.
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Adverse Events
Diphenhydramine 50 mg IV Infusion
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place