Trial Outcomes & Findings for Acetylcholinesterase Inhibitors to Improve Cognitive Function and Overall Rehabilitation After a Stroke (NCT NCT00227994)

Results Overview

Score on Functional Independence Measure (FIM) motor score, where 7 indicates total assistance/complete dependence and 91 is complete independence

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

Measured at weeks 0 and 12

Results posted on

2017-12-11

Participant Flow

40 participants received study medication

Participant milestones

Participant milestones
Measure	Galantamine Galantamine for 12 weeks Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study.	Donepezil Donepezil for 12 weeks Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks.
Overall Study STARTED	20	20
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acetylcholinesterase Inhibitors to Improve Cognitive Function and Overall Rehabilitation After a Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Galantamine n=13 Participants Galantamine for 12 weeks Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study.	Donepezil n=13 Participants Donepezil for 12 weeks Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks.	Total n=26 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Age, Continuous	69.9 years STANDARD_DEVIATION 7.5 • n=5 Participants	69.1 years STANDARD_DEVIATION 6.4 • n=7 Participants	69.5 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	13 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at weeks 0 and 12

Score on Functional Independence Measure (FIM) motor score, where 7 indicates total assistance/complete dependence and 91 is complete independence

Outcome measures

Outcome measures
Measure	Galantamine n=13 Participants Galantamine for 12 weeks Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study.	Donepezil n=13 Participants Donepezil for 12 weeks Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks.
Physical Function (Measured by the FIM-motor) Baseline FIM	47.1 units on a scale Standard Deviation 9.7	49.4 units on a scale Standard Deviation 8.34
Physical Function (Measured by the FIM-motor) Week 12 FIM	73.1 units on a scale Standard Deviation 16.5	87.4 units on a scale Standard Deviation 5.2

SECONDARY outcome

Timeframe: Measured throughout the study

Number of participants who withdrew due to side effects.

Outcome measures

Outcome measures
Measure	Galantamine n=20 Participants Galantamine for 12 weeks Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study.	Donepezil n=20 Participants Donepezil for 12 weeks Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks.
Medication Tolerability	5 participants	5 participants

Adverse Events

Galantamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Donepezil

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

Eric Lenze

Washington University School of Medicine

Phone: 314-362-1671

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60