Trial Outcomes & Findings for The Effects of the Rivastigmine Patch on Parkinson's Disease With Memory and/or Thinking Problems (NCT NCT00988117)

Results Overview

Fractional amplitude of low frequency fluctuations (fALFF) was used to measure brain activity. This metric is derived from task-free functional magnetic resonance imaging (fMRI) and represents the power of regional spontaneous and intrinsic brain activity at the local, voxel-wise level while the subject is at rest. More specifically, the amplitude of low-frequency fluctuations (ALFF) is the total power in the low-frequency range, and fALFF is calculated by dividing ALFF by the total power across all measurable frequencies. Whereas ALFF values increase near blood vessels and cerebrospinal fluid (CSF), likely due to pulsations in those areas, fALFF is less susceptible to artifactual signals. We measured change in these ratio scores post-treatment minus baseline and present in z-score units.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2014-02-26

Participant Flow

Patients were recruited from UCSF movement disorders neurologists, regional Parkinson's Disease (PD) support group meetings and advertisements in PD newsletters between 4/2010 and 1/2011.

Participant milestones

Participant milestones
Measure	Rivastigmine The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
4.6 mg/24 Hours From Baseline to Week 4 STARTED	15
4.6 mg/24 Hours From Baseline to Week 4 COMPLETED	14
4.6 mg/24 Hours From Baseline to Week 4 NOT COMPLETED	1
9.5 mg/24 Hours From Week 4 to 12 STARTED	14
9.5 mg/24 Hours From Week 4 to 12 COMPLETED	12
9.5 mg/24 Hours From Week 4 to 12 NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Rivastigmine The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
4.6 mg/24 Hours From Baseline to Week 4 Adverse Event	1
9.5 mg/24 Hours From Week 4 to 12 Adverse Event	2

Baseline Characteristics

The Effects of the Rivastigmine Patch on Parkinson's Disease With Memory and/or Thinking Problems

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours n=12 Participants The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	12 Participants n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	9 Participants n=99 Participants
Region of Enrollment United States	12 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: All patients who completed the study were included.

Fractional amplitude of low frequency fluctuations (fALFF) was used to measure brain activity. This metric is derived from task-free functional magnetic resonance imaging (fMRI) and represents the power of regional spontaneous and intrinsic brain activity at the local, voxel-wise level while the subject is at rest. More specifically, the amplitude of low-frequency fluctuations (ALFF) is the total power in the low-frequency range, and fALFF is calculated by dividing ALFF by the total power across all measurable frequencies. Whereas ALFF values increase near blood vessels and cerebrospinal fluid (CSF), likely due to pulsations in those areas, fALFF is less susceptible to artifactual signals. We measured change in these ratio scores post-treatment minus baseline and present in z-score units.

Outcome measures

Outcome measures
Measure	Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours n=12 Participants The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
Resting State Functional Activity Change From Baseline to 12 Weeks left inferior frontal gyrus / premotor fALFF chang	1.13 z-score Standard Deviation 1
Resting State Functional Activity Change From Baseline to 12 Weeks left supplementary motor area fALFF change	.79 z-score Standard Deviation 1

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Data were missing for two of the patients on the CPT post-treatment due to a computer error.

On the Continuous Performance Test (CPT), subjects press the spacebar quickly when they see a target image (a white star; 150 trials), and withhold response when they see a non-target image (5 randomly sampled white shapes; 150 trials). The inter-stimulus interval is randomly sampled from 1.5s, 2.5s, or 4s. Performance is measured by the median reaction time (milliseconds) on accurate target trials.

Outcome measures

Outcome measures
Measure	Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours n=10 Participants The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
Pre-post Change in Continuous Performance Test of Attention (Median Reaction Time) Baseline	579 milliseconds Full Range 108 • Interval 431.0 to 751.0
Pre-post Change in Continuous Performance Test of Attention (Median Reaction Time) Post-treatment	571 milliseconds Full Range 108 • Interval 456.0 to 742.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

The Montreal Cognitive Assessment (MoCA) was used as measure of global cognitive function. Total scores range from 0 (worst) to 30 (best).

Outcome measures

Outcome measures
Measure	Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours n=12 Participants The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
Pre-post Change in Montreal Cognitive Assessment Baseline	23 units on a scale Standard Deviation 4.8
Pre-post Change in Montreal Cognitive Assessment Post-treatment	24.3 units on a scale Standard Deviation 4.7

Adverse Events

Rivastigmine 4.6mg/24 Hours

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Rivastigmine 9.5 mg/24 Hours

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rivastigmine 4.6mg/24 Hours n=15 participants at risk The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4.	Rivastigmine 9.5 mg/24 Hours n=14 participants at risk The Exelon patch was administered at a dosage of 9.5 mg/24 hours from week 4 to 12.
Nervous system disorders lightheadedness	6.7% 1/15 • Number of events 1	0.00% 0/14
Gastrointestinal disorders gastrointestinal distress	0.00% 0/15	14.3% 2/14 • Number of events 2

Additional Information

Dr. Bruce Miller

UCaliforniaSF

Phone: 415-476-5569

Email: [email protected]; [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place