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Trial · NCT00912808

Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease

NCT00912808, Not applicable, Completed, Oregon Health and Science University; results first posted 2011-08-15

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease. Trials, record NCT00912808. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00912808

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease
NCT number
NCT00912808
Status
Completed
Phases
Not applicable
Enrollment
23 participants, actual
Lead sponsor
Oregon Health and Science University
Conditions
Parkinson's Disease
Interventions
Donepezil, Sugar Pill (placebo)
First posted
2009-06-03
Last updated
2018-05-08
Results first posted
2011-08-15
Limitations and caveats
Small number of subjects and lack of objective measurement to quantify falls. The most difficult condition to exclude was co-existing freezing of gait.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryFall Frequency Per Day6 weeks
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.
SecondaryFrequency of Near Falls Per Day6 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.

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYFall Frequency Per Day6 weeksNumber Falls/DayMEAN
SECONDARYFrequency of Near Falls Per Day6 weeksNumber Near Falls/DayMEAN

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Fall Frequency Per DayDonepezil0.13Standard Error 0.13Number Falls/Day
Fall Frequency Per DayPlacebo0.25Standard Error 0.34Number Falls/Day
Frequency of Near Falls Per DayDonepezil2.50Standard Error 4.10Number Near Falls/Day
Frequency of Near Falls Per DayPlacebo2.04Standard Error 2.08Number Near Falls/Day

Participant flow22

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
First Intervention (6 Weeks)STARTEDDonepezil (6 Weeks), Washout (3 Weeks), Placebo (6 Weeks)11
First Intervention (6 Weeks)STARTEDPlacebo (6 Weeks), Washout (3 Weeks), Donepezil (6 Weeks)12
First Intervention (6 Weeks)Received InterventionDonepezil (6 Weeks), Washout (3 Weeks), Placebo (6 Weeks)11
First Intervention (6 Weeks)Received InterventionPlacebo (6 Weeks), Washout (3 Weeks), Donepezil (6 Weeks)12
First Intervention (6 Weeks)COMPLETEDDonepezil (6 Weeks), Washout (3 Weeks), Placebo (6 Weeks)9
First Intervention (6 Weeks)COMPLETEDPlacebo (6 Weeks), Washout (3 Weeks), Donepezil (6 Weeks)11
First Intervention (6 Weeks)NOT COMPLETEDDonepezil (6 Weeks), Washout (3 Weeks), Placebo (6 Weeks)2
First Intervention (6 Weeks)NOT COMPLETEDPlacebo (6 Weeks), Washout (3 Weeks), Donepezil (6 Weeks)1
WashoutSTARTEDDonepezil (6 Weeks), Washout (3 Weeks), Placebo (6 Weeks)9
WashoutSTARTEDPlacebo (6 Weeks), Washout (3 Weeks), Donepezil (6 Weeks)11

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityDonepezil Then Placebo
Total, all-cause mortalityPlacebo Then Donepezil
Total, other adverse eventsDonepezil Then Placebo011
Total, other adverse eventsPlacebo Then Donepezil012
Total, serious adverse eventsDonepezil Then Placebo011
Total, serious adverse eventsPlacebo Then Donepezil012

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Donepezil Then Placebo vs Placebo Then Donepezil: serious adverse events

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00912808

GET https://conductscience.org/api/trials/v1/NCT00912808/flow?page=2