Trial Outcomes & Findings for Boost Study 21270 (Cognition) (NCT NCT05990335)

NCT ID: NCT05990335

Last Updated: 2024-12-18

Results Overview

Percentage of participants completing minimum required weekly interactions

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 124 participants
• Primary outcome timeframe: At 8 weeks
• Results posted on: 2024-12-18

Participant Flow

Participant milestones

Measure	Cognition Exercises Group I Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions mHealth application (custom): Smartphone based application designed to engage user executive functions	Cognition Exercises Group C Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions mHealth application (custom): Smartphone based application designed to engage user executive functions
Overall Study STARTED	64	60
Overall Study COMPLETED	64	60
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Boost Study 21270 (Cognition)

Baseline characteristics by cohort

Measure	Cognition Exercises Group I n=64 Participants Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions mHealth application (custom): Smartphone based application designed to engage user executive functions	Cognition Exercises Group C n=60 Participants Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions mHealth application (custom): Smartphone based application designed to engage user executive functions	Total n=124 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	63 Participants n=5 Participants	60 Participants n=7 Participants	123 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex/Gender, Customized Male	17 Participants n=5 Participants	26 Participants n=7 Participants	43 Participants n=5 Participants
Sex/Gender, Customized Female	37 Participants n=5 Participants	29 Participants n=7 Participants	66 Participants n=5 Participants
Sex/Gender, Customized Transgender Male or Transgender Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex/Gender, Customized Not Reported	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Black / African American	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized White	41 Participants n=5 Participants	36 Participants n=7 Participants	77 Participants n=5 Participants
Race/Ethnicity, Customized Unreported	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	64 Participants n=5 Participants	60 Participants n=7 Participants	124 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 8 weeks

Percentage of participants completing minimum required weekly interactions

Outcome measures

Measure	Cognition Exercises Group I n=64 Participants Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions mHealth application (custom): Smartphone based application designed to engage user executive functions	Cognition Exercises Group C n=60 Participants Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions mHealth application (custom): Smartphone based application designed to engage user executive functions
Task Completion Rate	66 Percentage of eligible participants Standard Deviation 15	57 Percentage of eligible participants Standard Deviation 19

SECONDARY outcome

Timeframe: At 8 weeks

Population: Subgroup of participants in each arm completing all study weeks and requested activities, were analyzed

Change in Human Hypothetical Choice scale (higher scores indicate a better outcome, minimum value 0 to maximum value 1), calculated as value at 8 weeks minus value at 1 week

Outcome measures

Measure	Cognition Exercises Group I n=21 Participants Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions mHealth application (custom): Smartphone based application designed to engage user executive functions	Cognition Exercises Group C n=29 Participants Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions mHealth application (custom): Smartphone based application designed to engage user executive functions
Change in Task Performance	0.62 units on a scale Standard Error 0.03	0.62 units on a scale Standard Error 0.04

Adverse Events

Cognition Exercises Group I

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cognition Exercises Group C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Kansas State

Phone: (785) 532-6850

Email: external+studydirector@nxtech.co

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place