Trial Outcomes & Findings for Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease (NCT NCT00912808)

Last Updated: 2018-05-08

Results Overview

The primary outcomes were fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for six weeks per phase. Falls were defined as landing on the floor. Fall frequency is the number of reported falls divided by the number of days reported. Postcards were mailed back to the investigator weekly.

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

6 weeks

Results posted on

2018-05-08

Participant Flow

Adult subjects were those diagnosed with probable idiopathic PD, defined as manifesting two of three cardinal features (tremor, rigidity, bradykinesia), without any other historical or physical signs to suggest another diagnosis, and were recruited from the Oregon Health and Science University (OHSU) Movement Disorders clinic.

This is a cross-over treatment trial. Each drug phase, donepezil or identical placebo, lasted 6 weeks, with a three week washout period in between. In each drug phase, subjects were instructed to take one tablet (mg of donepezil or placebo) for three weeks and to increase to two tablets (10 mg) for the remaining three weeks.

Participant milestones

Participant milestones
Measure	Donepezil (6 Weeks), Washout (3 Weeks), Placebo (6 Weeks) Donepezil 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then Nothing weeks 7-9 then Placebo (sugar pill) 5 mg qam weeks 10-13, 10 mg qam weeks 14-16	Placebo (6 Weeks), Washout (3 Weeks), Donepezil (6 Weeks) Placebo (sugar pill) 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then Nothing weeks 7-9 then Donepezil 5 mg qam weeks 10-13, 10 mg qam weeks 14-16
First Intervention (6 Weeks) STARTED	11	12
First Intervention (6 Weeks) Received Intervention	11	12
First Intervention (6 Weeks) COMPLETED	9	11
First Intervention (6 Weeks) NOT COMPLETED	2	1
Washout STARTED	9	11
Washout COMPLETED	9	10
Washout NOT COMPLETED	0	1
Second Intervention (6 Weeks) STARTED	9	10
Second Intervention (6 Weeks) Received Intervention	9	10
Second Intervention (6 Weeks) COMPLETED	8	9
Second Intervention (6 Weeks) NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Donepezil (6 Weeks), Washout (3 Weeks), Placebo (6 Weeks) Donepezil 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then Nothing weeks 7-9 then Placebo (sugar pill) 5 mg qam weeks 10-13, 10 mg qam weeks 14-16	Placebo (6 Weeks), Washout (3 Weeks), Donepezil (6 Weeks) Placebo (sugar pill) 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then Nothing weeks 7-9 then Donepezil 5 mg qam weeks 10-13, 10 mg qam weeks 14-16
First Intervention (6 Weeks) Adverse Event	2	1
Washout Withdrawal by Subject	0	1
Second Intervention (6 Weeks) Adverse Event	0	1
Second Intervention (6 Weeks) Withdrawal by Subject	1	0

Baseline Characteristics

Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Donepezil (6 Weeks), Washout (3 Weeks), Placebo (6 Weeks) n=11 Participants Donepezil 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then Nothing weeks 7-9 then Placebo (sugar pill) 5 mg qam weeks 10-13, 10 mg qam weeks 14-16	Placebo (6 Weeks), Washout (3 Weeks), Placebo (6 Weeks) n=12 Participants Placebo (sugar pill) 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then Nothing weeks 7-9 then Donepezil 5 mg qam weeks 10-13, 10 mg qam weeks 14-16	Total n=23 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	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Age, Continuous	71.5 years STANDARD_DEVIATION 10.2 • n=5 Participants	66.4 years STANDARD_DEVIATION 11.5 • n=7 Participants	68.4 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	12 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Donepezil n=8 Participants Participants who received Donepezil tablet (matching 5 mg for the first 3 weeks then 10 mg for the next 3 weeks) each morning in either the first or last 6 weeks of the study.	Placebo n=11 Participants Participants who received Placebo tablet (matching Donepezil) each morning in either the first or last 6 weeks of the study.
Fall Frequency Per Day	0.13 Number Falls/Day Standard Error 0.13	0.25 Number Falls/Day Standard Error 0.34

SECONDARY outcome

Timeframe: 6 weeks

The secondary outcome was near fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for six weeks per phase. Near falls were defined as a fall that did not land on the floor (for example grabbing a handrail or a table). Near fall frequency is the number of reported near falls divided by the number of days reported. Postcards were mailed back to the investigator weekly.

Outcome measures

Outcome measures
Measure	Donepezil n=8 Participants Participants who received Donepezil tablet (matching 5 mg for the first 3 weeks then 10 mg for the next 3 weeks) each morning in either the first or last 6 weeks of the study.	Placebo n=11 Participants Participants who received Placebo tablet (matching Donepezil) each morning in either the first or last 6 weeks of the study.
Frequency of Near Falls Per Day	2.50 Number Near Falls/Day Standard Error 4.10	2.04 Number Near Falls/Day Standard Error 2.08

Adverse Events

Donepezil Then Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Then 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

Kathryn Chung, MD

Oregon Health & Science University

Phone: 503 220 8262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place