Trial Outcomes & Findings for Intensive Instruction on the Use of Aricept (NCT NCT01972204)

NCT ID: NCT01972204

Last Updated: 2019-06-03

Results Overview

Number of Participants who Continue the Medication for 48 weeks

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 125 participants
• Primary outcome timeframe: 48 weeks
• Results posted on: 2019-06-03

Participant Flow

Participant milestones

Measure	Intensive Adherence Instruction Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure Intensive adherence instruction: Instruction with educational brochure	Control The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice. Control: Instruction as per usual practice
Overall Study STARTED	62	63
Overall Study COMPLETED	58	59
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intensive Instruction on the Use of Aricept

Baseline characteristics by cohort

Measure	Intensive Adherence Instruction n=58 Participants Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure Intensive adherence instruction: Instruction with educational brochure	Control n=59 Participants The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice. Control: Instruction as per usual practice	Total n=117 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	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	58 Participants n=5 Participants	58 Participants n=7 Participants	116 Participants n=5 Participants
Age, Continuous	79.7 years STANDARD_DEVIATION 7.23 • n=5 Participants	80.2 years STANDARD_DEVIATION 6.99 • n=7 Participants	79.9 years STANDARD_DEVIATION 7.08 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	31 Participants n=7 Participants	68 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	28 Participants n=7 Participants	49 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	58 Participants n=5 Participants	59 Participants n=7 Participants	117 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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 Japan	58 Participants n=5 Participants	59 Participants n=7 Participants	117 Participants n=5 Participants
Treatmnent for alzheimer's disease before study	44 participants n=5 Participants	48 participants n=7 Participants	92 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

Number of Participants who Continue the Medication for 48 weeks

Outcome measures

Measure	Intensive Adherence Instruction n=58 Participants Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure Intensive adherence instruction: Instruction with educational brochure	Control n=59 Participants The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice. Control: Instruction as per usual practice
Number of Participants With Medication Continuation	36 participants	39 participants

SECONDARY outcome

Timeframe: 48 weeks

Reasons for discontinuation of the Medication

Outcome measures

Measure	Intensive Adherence Instruction n=22 Participants Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure Intensive adherence instruction: Instruction with educational brochure	Control n=20 Participants The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice. Control: Instruction as per usual practice
Reasons for Discontinuation Pysician's decision	17 Participants	11 Participants
Reasons for Discontinuation Participant's wish	2 Participants	4 Participants
Reasons for Discontinuation Caretaker's wish	3 Participants	5 Participants

SECONDARY outcome

Timeframe: 48 weeks

Number of Participants who descontinue the Clinical Trial Medication due to Change to Alicept (not for clinical trial) or Generics

Outcome measures

Measure	Intensive Adherence Instruction n=58 Participants Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure Intensive adherence instruction: Instruction with educational brochure	Control n=59 Participants The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice. Control: Instruction as per usual practice
Number of Participants With Medication Discontinuation Due to Change to Alicept or Generics	5 participants	7 participants

SECONDARY outcome

Timeframe: Week 2, 12, 24, 48

Adverse Events for each arm

Outcome measures

Measure	Intensive Adherence Instruction n=58 Participants Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure Intensive adherence instruction: Instruction with educational brochure	Control n=59 Participants The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice. Control: Instruction as per usual practice
Adverse Events	33 participants	23 participants

Adverse Events

Intensive Adherence Instruction

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intensive Adherence Instruction n=58 participants at risk Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure Intensive adherence instruction: Instruction with educational brochure	Control n=59 participants at risk The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice. Control: Instruction as per usual practice
Gastrointestinal disorders nausea	5.2% 3/58 • Number of events 3 • 1 year	1.7% 1/59 • Number of events 1 • 1 year
Gastrointestinal disorders vomiting	1.7% 1/58 • Number of events 1 • 1 year	8.5% 5/59 • Number of events 5 • 1 year
Injury, poisoning and procedural complications contusion	8.6% 5/58 • Number of events 5 • 1 year	5.1% 3/59 • Number of events 3 • 1 year
Metabolism and nutrition disorders decreased appetite	5.2% 3/58 • Number of events 3 • 1 year	6.8% 4/59 • Number of events 4 • 1 year
Musculoskeletal and connective tissue disorders back pain	5.2% 3/58 • Number of events 3 • 1 year	0.00% 0/59 • 1 year
Vascular disorders hypertention	8.6% 5/58 • Number of events 5 • 1 year	1.7% 1/59 • Number of events 1 • 1 year

Additional Information

Tomoko Machida (Director)

Mirai Iryo Research Center

Phone: 81-3-3263-4801

Email: machida@mirai-iryo.com

Results disclosure agreements

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