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CompletedPhase 4Results posted

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

The Effects of the Rivastigmine Patch on Attention and Behavior in Parkinson's Disease With Dementia (PDD)

Lead sponsor

University of California, San Francisco

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Lewy body dementia

Key I/E criteria

•Parkinson's disease dementia•MMSE ≥21

Primary endpoints

•Resting State Functional Activity Change•Pre-post Change in Continuous Performance Test of Attention

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCENA7 13D US45T

NCT IDNCT00988117

Timeline

Milestones

Study first posted2009-10-01estimated

Study start2010-04 (month precision)

Primary completion2011-04actual (month precision)

Study completion2011-04actual (month precision)

Last update posted2014-02-26estimated

Results first posted2014-02-26estimated

Assets

Drug assets

Rivastigmine

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Must meet research criteria for Parkinson's Disease with Dementia (PDD)

•Males and females, ages between 55 and 100

•Able to undergo psychometric testing

•Mini-Mental State Examination ≥ 21 and Clinical Dementia Rating < 2

•Reliable informant with frequent contact with patient

Exclusion criteria

•Non-English speaking, as cognitive tests will be in English

•Evidence of other neurological or psychiatric disorders which preclude diagnosis of PDD (including, but not limited to, stroke, any psychotic disorder, severe bipolar or unipolar depression, seizure disorder, or head injury with loss of consciousness) within the past year

•Concurrent treatment with any acetylcholinesterase inhibitors (including rivastigmine in pill or patch form), antipsychotic agents (excluding quetiapine in dosages of 150 mg and lower, abilify and geodon as these medications are commonly used in treatment of Parkinson's Disease (PD) psychosis and should not affect results of study), mood stabilizers (valproate or lithium) or benzodiazepines (other than temazepam or zolpidem)

•Positive urine drug screen or suspected alcohol or substance abuse within last 1 year

•Current malignancy, or any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease. If the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included

•Systolic blood pressure over 180 or less than 90 mm Hg. Diastolic blood pressure not greater than 105 or less than 50 mm Hg

•ECG is abnormal and judged to be clinically significant by the investigator

•Use of investigational drugs or participation in investigational drug studies within 30 days of screening

•Geriatric Depression Score score > 15/30

•Hachinski score > 4

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Executive function / language

Neuroimaging

Global cognition

2 endpoints

Secondary/protocol endpoint

Pre-post Change in Montreal Cognitive Assessment

Time frame:Baseline and 12 weeks

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Secondary/registry result

Pre-post Change in Montreal Cognitive Assessment

Time frame:Baseline and 12 weeks

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Rivastigmine 4.6mg/24 Hours to 9.5mg/24 HoursBaselinen=12 Participants	23	4.8
Post-treatmentn=12 Participants	24.3	4.7

pearson's r correlation.18p.58Regression, Linear

correlation with left premotor / inferior frontal gyri falff change

pearson's correlation coefficient.26p.41Regression, Linear

correlation with left supplementary motor area falff change

Executive function / language

2 endpoints

Primary/protocol endpoint

Pre-post Change in Continuous Performance Test of Attention (Median Reaction Time)

Time frame:Baseline and 12 weeks

change from baseline, improvement

Primary/registry result

Pre-post Change in Continuous Performance Test of Attention (Median Reaction Time)

Time frame:Baseline and 12 weeks

change from baseline, improvement

Posted result

Group	Value (median), milliseconds	Reported spread / bounds
Rivastigmine 4.6mg/24 Hours to 9.5mg/24 HoursBaselinen=10 Participants	579	108431 - 751
Post-treatmentn=10 Participants	571	108456 - 742

pearson's r correlation coefficient-.82p<.01Regression, Linear

correlation with left inferior frontal gyrus / premotor falff change

pearson's correlation coefficient-.35p.36Regression, Linear

correlation with left supplementary motor area falff change

Neuroimaging

2 endpoints

Primary/protocol endpoint

Resting State Functional Activity Change From Baseline to 12 Weeks

Time frame:Baseline and 12 weeks

change from baseline, improvement

Primary/registry result

Resting State Functional Activity Change From Baseline to 12 Weeks

Time frame:Baseline and 12 weeks

change from baseline, improvement

Posted result

Group	Value (mean), z-score	Standard deviation
Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hoursleft inferior frontal gyrus / premotor fALFF changn=12 Participants	1.13	1
left supplementary motor area fALFF changen=12 Participants	.79	1

Tscore5.19p<0.01t-test, 2 sided

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Possin KL, Kang GA, Guo C, Fine EM, Trujillo AJ, Racine CA, Wilheim R, Johnson ET, Witt JL, Seeley WW, Miller BL, Kramer JH. Rivastigmine is associated with restoration of left frontal brain activity in Parkinson's disease. Mov Disord. 2013 Sep;28(10):1384-90. doi: 10.1002/mds.25575. Epub 2013 Jul 11.
PMID23847120via RESULT

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.