Trial Outcomes & Findings for Methylphenidate for Apathy in Alzheimer's Dementia: A Controlled Study (NCT NCT00495820)

Last Updated: 2015-11-20

Results Overview

The Apathy Evaluation Scale (AES) has been specifically developed to assess apathy and discriminate it from depression. This 18 item scale with score ranging from 18 to 72, assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks. Higher scores indicate worsening apathy.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

At 12 weeks

Results posted on

2015-11-20

Participant Flow

60 subjects meeting the inclusion and exclusion criteria were recruited from outpatient clinics at the Nebraska Western Iowa Health Care System between 2006-2009.

Participant milestones

Participant milestones
Measure	Arm 1 Methylphenidate Methylphenidate: Subject will receive 5mg BID for two weeks then 10mg BID until week 12 of the study.	Arm 2 Placebo Placebo: Standard inactive pill.
Overall Study STARTED	30	30
Overall Study COMPLETED	29	29
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 Methylphenidate Methylphenidate: Subject will receive 5mg BID for two weeks then 10mg BID until week 12 of the study.	Arm 2 Placebo Placebo: Standard inactive pill.
Overall Study Adverse Event	1	1

Baseline Characteristics

Methylphenidate for Apathy in Alzheimer's Dementia: A Controlled Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=30 Participants Methylphenidate Methylphenidate: Subject will receive 5mg BID for two weeks then 10mg BID until week 12 of the study.	Arm 2 n=30 Participants Placebo Placebo: Standard inactive pill.	Total n=60 Participants Total of all reporting groups
Age, Continuous	77.5 years STANDARD_DEVIATION 7.9 • n=93 Participants	76.1 years STANDARD_DEVIATION 8.4 • n=4 Participants	76.6 years STANDARD_DEVIATION 7.9 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	30 Participants n=93 Participants	30 Participants n=4 Participants	60 Participants n=27 Participants
Region of Enrollment United States	30 participants n=93 Participants	30 participants n=4 Participants	60 participants n=27 Participants
Apathy Evaluation Scale	51.9 units on a scale STANDARD_DEVIATION 7.1 • n=93 Participants	47.6 units on a scale STANDARD_DEVIATION 5.8 • n=4 Participants	49.7 units on a scale STANDARD_DEVIATION 6.8 • n=27 Participants
Mini-mental State Examination (MMSE)	23.7 units on a scale STANDARD_DEVIATION 2.5 • n=93 Participants	24 units on a scale STANDARD_DEVIATION 2.6 • n=4 Participants	23.8 units on a scale STANDARD_DEVIATION 2.5 • n=27 Participants
Modified Mini-Mental State Examination (3MS)	80.1 units on a scale STANDARD_DEVIATION 9 • n=93 Participants	82.6 units on a scale STANDARD_DEVIATION 10 • n=4 Participants	81.3 units on a scale STANDARD_DEVIATION 9.5 • n=27 Participants
Activities of Daily Living	21.3 units on a scale STANDARD_DEVIATION 2.7 • n=93 Participants	22.9 units on a scale STANDARD_DEVIATION 2.2 • n=4 Participants	22 units on a scale STANDARD_DEVIATION 2.6 • n=27 Participants
The Executive Interview (EXIT-25)	16.9 units on a scale STANDARD_DEVIATION 6.3 • n=93 Participants	16.8 units on a scale STANDARD_DEVIATION 6.6 • n=4 Participants	16.8 units on a scale STANDARD_DEVIATION 6.4 • n=27 Participants
Zarit Burden Scale	28.1 units on a scale STANDARD_DEVIATION 13 • n=93 Participants	25.3 units on a scale STANDARD_DEVIATION 13.3 • n=4 Participants	26.9 units on a scale STANDARD_DEVIATION 13 • n=27 Participants
Clinical Global Impression-severity (CGI-S)	5.5 units on a scale STANDARD_DEVIATION 0.6 • n=93 Participants	5.1 units on a scale STANDARD_DEVIATION 0.6 • n=4 Participants	5.3 units on a scale STANDARD_DEVIATION 0.6 • n=27 Participants

PRIMARY outcome

Timeframe: At 12 weeks

Outcome measures

Outcome measures
Measure	Methylphenidate Group n=30 Participants Subjects randomized to this group received methylphenidate	Placebo Group n=30 Participants Subjects randomized to this group received placebo
Apathy Evaluation Scale Score at 12 Weeks	38.2 units on a scale Standard Deviation 9.1	43.6 units on a scale Standard Deviation 7.5

SECONDARY outcome

Timeframe: At 12 weeks

Mini-mental State Examination (MMSE) is a commonly used screening measure for cognition with questions pertaining to orientation, registration, recall, visuo-spatial construction, attention span etc. Score on MMSE ranges from 0-30, higher scores indicating improving cognition

Outcome measures

Outcome measures
Measure	Methylphenidate Group n=30 Participants Subjects randomized to this group received methylphenidate	Placebo Group n=30 Participants Subjects randomized to this group received placebo
Mini-mental State Examination (MMSE) at 12 Weeks	25.8 units on a scale Standard Deviation 2.7	23.6 units on a scale Standard Deviation 4

SECONDARY outcome

Timeframe: At 12 weeks

The Clinical Global Impression scale is an observational scale of global evaluation, which assesses the change in degree of illness in relation to the original assessment. The severity sub-scale reported below ranges from 1-7 wherein higher scores indicate worsening severity of illness.

Outcome measures

Outcome measures
Measure	Methylphenidate Group n=30 Participants Subjects randomized to this group received methylphenidate	Placebo Group n=30 Participants Subjects randomized to this group received placebo
Clinical Global Impression	3.9 units on a scale Standard Deviation 1.1	4.8 units on a scale Standard Deviation 0.6

Adverse Events

Methylphenidate Group

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Methylphenidate Group n=30 participants at risk Subjects randomized to this group received methylphenidate	Placebo Group n=30 participants at risk Subjects randomized to this group received methylphenidate
Gastrointestinal disorders Nausea	16.7% 5/30 • Number of events 7	13.3% 4/30 • Number of events 4
Cardiac disorders Increased blood pressure	6.7% 2/30 • Number of events 3	3.3% 1/30 • Number of events 1
Gastrointestinal disorders Weight loss	6.7% 2/30 • Number of events 2	3.3% 1/30 • Number of events 1
Nervous system disorders headache	10.0% 3/30 • Number of events 3	16.7% 5/30 • Number of events 6
Nervous system disorders restlessness	3.3% 1/30 • Number of events 1	10.0% 3/30 • Number of events 3
Psychiatric disorders Insomnia	3.3% 1/30 • Number of events 1	6.7% 2/30 • Number of events 3

Additional Information

Prasad Padala, MD, MS, Associate Director for Clinical Programs, GRECC

Central Arkansas Veterans Healthcare System

Phone: 5012572537

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place