Trial Outcomes & Findings for Treatment of Apathy in Alzheimer's Disease With Modafinil (NCT NCT01172145)

Results Overview

The Frontal Systems Behavior Scale. Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

22 participants

Primary outcome timeframe

at baseline

Results posted on

2011-03-04

Participant Flow

Participants were recruited from a Memory Disorders Clinic and the community between 2005 and 2007

Participant milestones

Participant milestones
Measure	Cholinesterase Inhibitor Only participants who received placebo	Cholinesterase Plus Modafinil participants who received modafinil (200 mg per day)
Overall Study STARTED	11	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Apathy in Alzheimer's Disease With Modafinil

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cholinesterase Inhibitor Only n=11 Participants participants who received placebo	Cholinesterase Plus Modafinil n=11 Participants participants who received modafinil (200 mg per day)	Total n=22 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	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Age Continuous	79.36 years STANDARD_DEVIATION 7.62 • n=5 Participants	75.27 years STANDARD_DEVIATION 8.34 • n=7 Participants	77.32 years STANDARD_DEVIATION 8.07 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: at baseline

The Frontal Systems Behavior Scale. Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.

Outcome measures

Outcome measures
Measure	Cholinesterase Inhibitor Only n=11 Participants participants who received placebo	Cholinesterase Plus Modafinil n=11 Participants participants who received modafinil (200 mg per day)
Apathy	88.91 T-score Standard Deviation 11.95	95.64 T-score Standard Deviation 10.79

PRIMARY outcome

Timeframe: after 8 weeks of treatment

The Frontal Systems Behavior Scale.Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within the average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.

Outcome measures

Outcome measures
Measure	Cholinesterase Inhibitor Only n=11 Participants participants who received placebo	Cholinesterase Plus Modafinil n=11 Participants participants who received modafinil (200 mg per day)
Apathy	82.09 T-score Standard Deviation 13.52	89.09 T-score Standard Deviation 9.61

SECONDARY outcome

Timeframe: at baseline

Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.

Outcome measures

Outcome measures
Measure	Cholinesterase Inhibitor Only n=11 Participants participants who received placebo	Cholinesterase Plus Modafinil n=11 Participants participants who received modafinil (200 mg per day)
Lawton Brody Activities of Daily Living Questionnaire	19.00 raw score Standard Deviation 5.25	16.18 raw score Standard Deviation 4.81

SECONDARY outcome

Timeframe: at baseline

A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.

Outcome measures

Outcome measures
Measure	Cholinesterase Inhibitor Only n=11 Participants participants who received placebo	Cholinesterase Plus Modafinil n=11 Participants participants who received modafinil (200 mg per day)
The Direct Assessment of Functional Status Scale	89.09 raw score Standard Deviation 7.84	84.55 raw score Standard Deviation 16.11

SECONDARY outcome

Timeframe: at baseline

Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.

Outcome measures

Outcome measures
Measure	Cholinesterase Inhibitor Only n=11 Participants participants who received placebo	Cholinesterase Plus Modafinil n=11 Participants participants who received modafinil (200 mg per day)
Zarit Burden Inventory	28.36 raw score Standard Deviation 21.09	31.18 raw score Standard Deviation 8.73

SECONDARY outcome

Timeframe: after 8 weeks of treatment

Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.

Outcome measures

Outcome measures
Measure	Cholinesterase Inhibitor Only n=11 Participants participants who received placebo	Cholinesterase Plus Modafinil n=11 Participants participants who received modafinil (200 mg per day)
Lawton Brody Activities of Daily Living Questionnaire	19.00 raw score Standard Deviation 5.54	15.64 raw score Standard Deviation 5.43

SECONDARY outcome

Timeframe: after 8 weeks of treatment

A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.

Outcome measures

Outcome measures
Measure	Cholinesterase Inhibitor Only n=11 Participants participants who received placebo	Cholinesterase Plus Modafinil n=11 Participants participants who received modafinil (200 mg per day)
The Direct Assessment of Functional Status Scale	88.36 raw score Standard Deviation 8.35	85.27 raw score Standard Deviation 14.16

SECONDARY outcome

Timeframe: after 8 weeks of treatment

Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.

Outcome measures

Outcome measures
Measure	Cholinesterase Inhibitor Only n=11 Participants participants who received placebo	Cholinesterase Plus Modafinil n=11 Participants participants who received modafinil (200 mg per day)
Zarit Burden Inventory	30.00 raw score Standard Deviation 20.56	30.00 raw score Standard Deviation 4.17

Adverse Events

Cholinesterase Inhibitor Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cholinesterase Plus Modafinil

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cholinesterase Inhibitor Only n=11 participants at risk participants who received placebo	Cholinesterase Plus Modafinil n=11 participants at risk participants who received modafinil (200 mg per day)
Nervous system disorders Motor Tics	0.00% 0/11	9.1% 1/11 • Number of events 1

Additional Information

Laura L. Frakey

Brown University

Phone: 401-729-3163

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place