Trial Outcomes & Findings for Study to Demonstrate Cognitive Enhancing Effects of BF2.649 (NCT NCT00690274)

Last Updated: 2019-04-23

Results Overview

The Brief Visuospatial Memory Test-Revised (Delayed Recall) is a neuropsychological test to assess one's ability to recall a previously exposed stimuli. The t-score range (as being reported) is from 35-81, with higher scores being better and indicating being able to recall more items after a 45-minute delay. (The t-score is a score calculated from the individual score and based on each individual's age group.) The t-scores are then grouped together and reported as a mean with the standard deviation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

52 participants

Primary outcome timeframe

12 weeks

Results posted on

2019-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Volunteers are given Placebo, up to 20mg per day Placebo: up to 20mg per day	BF2.649 Volunteers are given BF2.649, up to 20mg per day BF2.649: up to 20mg per day
Overall Study STARTED	29	23
Overall Study COMPLETED	23	15
Overall Study NOT COMPLETED	6	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Demonstrate Cognitive Enhancing Effects of BF2.649

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=23 Participants Volunteers are given Placebo, up to 20mg per day Placebo: up to 20mg per day	BF2.649 n=15 Participants Volunteers are given BF2.649, up to 20mg per day BF2.649: up to 20mg per day	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	15 Participants n=7 Participants	38 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	11 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	14 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	10 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	23 Participants n=5 Participants	15 Participants n=7 Participants	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants Volunteers are given Placebo, up to 20mg per day Placebo: up to 20mg per day	BF2.649 n=15 Participants Volunteers are given BF2.649, up to 20mg per day BF2.649: up to 20mg per day
Changes in Delayed Recall From Baseline to 12 Weeks	40.2 t-score Standard Deviation 2.9	43.4 t-score Standard Deviation 3.5

SECONDARY outcome

Timeframe: 12 weeks

Montgomery-Asberg Depression Rating Scale (MADRS), a depression rating scale. The score can total from 0-60, with the higher score indicating more severe depressive symptoms. The scores indicate a change between baseline and 12 weeks.

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants Volunteers are given Placebo, up to 20mg per day Placebo: up to 20mg per day	BF2.649 n=15 Participants Volunteers are given BF2.649, up to 20mg per day BF2.649: up to 20mg per day
To Evaluate the Effect of BF2.649 on Symptom Severity Between Baseline and Week 12	0.5 scores on a scale Standard Deviation 1.5	-4.9 scores on a scale Standard Deviation 1.9

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BF2.649

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=23 participants at risk Volunteers are given Placebo, up to 20mg per day Placebo: up to 20mg per day	BF2.649 n=15 participants at risk Volunteers are given BF2.649, up to 20mg per day BF2.649: up to 20mg per day
Psychiatric disorders suicidality	0.00% 0/23	6.7% 1/15 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Carol A. Tamminga, MD

University of Texas Southwestern Medical Center

Phone: 214-645-2789

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place