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Parkinson's Disease DementiaPhase 3NCT00623103

Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)

A Phase 3 study testing Rivastigmine capsule and Rivastigmine transdermal patch in people with Parkinson's Disease Dementia, run by Novartis at 127 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately severe dementia associated with PD. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Parkinson's Disease Dementia
What is being tested?
Rivastigmine capsule and Rivastigmine transdermal patch
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
583 participants
Where
127 sitesin 13 countries
Study dates
Jan 2008to Nov 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of idiopathic Parkinson's disease, according to the UK Parkinson's disease Society Brain Bank criteria
  • Diagnosis of Parkinson's disease dementia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, with onset of symptoms of dementia at least 2 years following the first diagnosis of idiopathic Parkinson's disease
  • Mini Mental State Examination score of ≥10 and ≤ 26 (at Screening Visit only)

Who cannot join

  • An advanced, severe, or unstable disease of any type that may interfere with the primary and secondary variable evaluations
  • A score of 5 (wheelchair bound or bedridden) in the "on"-state on the Modified Hoehn and Yahr Staging (UPDRS Part V)
  • A current diagnosis of any primary neurodegenerative disorder other than idiopathic PD
  • A current diagnosis of any treatable dementia (hypothyroidism, syphilis, vitamin B12 or folate deficiency) that is verified by the investigator to be the cause of dementia.
  • A current diagnosis of probably vascular dementia according to the National Institute of Neurological Disorders and Stroke and the Association International pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN) criteria
  • A current diagnosis of a major depressive episode according to DSM-IV criteria
Show all 9Show fewer
  • A history of stereotaxic brain surgery for Parkinson's disease
  • A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to rivastigmine or to other cholinergic compounds
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

127 sites in 13 countries.

127 sites in 13 countries

Germany20 sites

  • Novartis Investigative Site

    Bad Nauheim, 61231

  • Novartis Investigative Site

    Beelitz-Heilstätten, 14547

  • Novartis Investigative site

    Berlin, 10713

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Bonn, 53105

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Hamburg, 21075

  • Novartis Investigative Site

    Kassel, 34128

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Leun-Biskirchen, 35638

  • Novartis Investigative Site

    Lubin, 15907

  • Novartis Investigative Site

    Mainz, D-55131

  • Novartis Investigative Site

    Marburg, 35032

  • Novartis Investigative Site

    München, 80804

  • Novartis Investigative Site

    München, 81675

  • Novartis Investigative Site

    Nuremberg, 90402

  • Novartis Investigative site

    Ulm, 89073

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Wolfach, 77709

Other trials in Germany

United States17 sites

  • Neurology & Neuroscience Associates, Inc.

    Akron, Ohio, 44302

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Progressive Clinical Research

    Bountiful, Utah, 84010

  • Neurology Specialists of Dallas

    Dallas, Texas, 75231

  • Square 1 Clinical Research

    Erie, Pennsylvania, 16506

  • Evanstan Northwestern Healthcare Medical Group

    Glenview, Illinois, 60026

  • Sunrise Clinical Research, Inc.

    Hollywood, Florida, 33021

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Neurological Associates

    Meridian, Idaho, 83646

  • Collier Neurologic Specialists

    Naples, Florida, 34102

  • 21st Century Neurology

    Phoenix, Arizona, 85004

  • Research Protocol Management Solutions

    Pittsburgh, Pennsylvania, 15243

  • Neurosearch, Inc.

    Reseda, California, 91335

  • Veterans Affairs Puget Sound Health Care System

    Seattle, Washington, 98108

  • Comprehensive Neurology Specialists, PC

    Suwanee, Georgia, 30024

  • Neurological Care of Central NY

    Syracuse, New York, 13210-1853

  • Neurosearch II, Inc.

    Ventura, California, 93003

Other trials in United States

Italy16 sites

  • Novartis Investigative Site

    Arcugnano, VI, 36057

  • Novartis Investigative Site

    Bari, BA, 70121

  • Novartis Investigative Site

    Bologna, BO, 40138

  • Novartis Investigative Site

    Brescia, BS, 25123

  • Novartis Investigative site

    Cassino, 03043

  • Novartis Investigative Site

    Foggia, FG, 71100

  • Novartis Investigative Site

    Lido di Camaiore, LU, 55041

  • Novartis Investigative Site

    Milan, MI, 20100

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Naples, 80138

  • Novartis Investigative Site

    Pozzilli, IS, 86077

  • Novartis Investigative Site

    Roma, RM, 00133

  • Novartis Investigative Site

    Roma, RM, 00163

  • Novartis Investigative Site

    Roma, RM, 00179

  • Novartis Investigative Site

    Roma, RM, 00185

  • Novartis Investigative Site

    Trieste, TS, 34149

Other trials in Italy

Canada13 sites

  • Novartis Investigative Site

    Calgary, Alberta, T2N 4N1

  • Novartis Investigative Site

    Greenfield Park, Quebec, J4V 2J2

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3J 3T1

  • Novartis Investigative Site

    Kitchener, Ontario, N2H 5Z8

  • Novartis Investigative Site

    London, Ontario, N6A 5A5

  • Novartis Investigative Site

    Montreal, Quebec, H2L 4M1

  • Novartis Investigative Site

    Montreal, Quebec, H3G 1A4

  • Novartis Investigative Site

    Ottawa, Ontario, K1G 4G3

  • Novartis Investigative Site

    Québec, Quebec, G1R 3X5

  • Novartis Investigative Site

    Regina, Saskatchewan, S4T 1A5

  • Novartis Investigative site

    Toronto, Ontario, M4N 3M5

  • Novartis Investigative Site

    Vancouver, British Columbia, V6T 2B5

  • Novartis Investigative Site

    Windsor, Ontario, N8X 5A6

Other trials in Canada

Netherlands10 sites

  • Novartis Investigative Site

    's-Hertogenbosch, JL, 5232

  • Novartis Investigative Site

    Blaricum, AN, 1261

  • Novartis Investigative Site

    Breda, CK, 4818

  • Novartis Investigative Site

    Enschede, ER, 7513

  • Novartis Investigative Site

    Groningen, GZ, 9713

  • Novartis Investigative Site

    Heerlen, PC, 6419

  • Novartis Investigative Site

    Maastricht, AZ, 6202

  • Novartis Investigative Site

    Sittard, 6131 BK

  • Novartis Investigative Site

    Tilburg, GC, 5022

  • Novartis Investigative Site

    Zwolle, AB, 8025

Other trials in Netherlands

France9 sites

  • Novartis Investigative Site

    Amiens, 80054

  • Novartis Investigative Site

    Clermont, 63003

  • Novartis Investigative Site

    Lille, 59037

  • Novartis Investigative Site

    Marseille, 13385

  • Novartis Investigative Site

    Montpellier, 34295

  • Novartis Investigative Site

    Paris, 75651

  • Novartis Investigative site

    Pessac, 33604

  • Novartis Investigative site

    Rennes, F-35043

  • Novartis Investigative Site

    Roanne, 42328

Other trials in France

Belgium8 sites

  • Novartis Investigative Site

    Antwerp, 2018

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Edegem, 2650

  • Novartis Investigative Site

    Jette, 1090

  • Novartis Investigative Site

    Kortrijk, 8500

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Wilrijk, 2610

Other trials in Belgium

United Kingdom8 sites

  • Novartis Investigative Site

    Blackburn, BB2 3HH

  • Novartis Investigative Site

    Blandford Forum, Dorset

  • Novartis Investigative Site

    Christchurch, Dorset, BH 232JX

  • Novartis Investigative Site

    Newcastle, NE4 5PL

  • Novartis Investigative Site

    Oxford, OX3 9DU

  • Novartis Investigative Site

    Peterborough, PE3 6DA

  • Novartis Investigative Site

    Southampton, SO30 3JB

  • Novartis Investigative Site

    Vale of Glamorgan, CF64 2XX

Other trials in United Kingdom

Turkey (Türkiye)7 sites

  • Novartis Investigative Site

    Adana, 01330

  • Novartis Investigative Site

    Antalya, 07059

  • Novartis Investigative Site

    Istanbul, 34093

  • Novartis Investigative Site

    Izmir, 35340

  • Novartis Investigative Site

    Kocaeli, 41380

  • Novartis Investigative Site

    Sihhiye/Ankara, 06100

  • Novartis Investigative Site

    Yenisehir/Izmir, 35120

Other trials in Turkey (Türkiye)

Australia5 sites

  • Novartis Investigative Site

    Heidelberg, Victoria, 3084

  • Novartis Investigative Site

    Kogarah, New South Wales, 2217

  • Novartis Investigative Site

    Malvern, Victoria, 3144

  • Novartis Investigative Site

    Melbourne, Victoria, 3050

  • Novartis Investigative Site

    Prahran, Victoria, 3181

Other trials in Australia

Austria5 sites

  • Novartis Investigative Site

    Graz, 8036

  • Novartis Investigative Site

    Innsbruck, 6020

  • Novartis Investigative Site

    Linz, 4020

  • Novartis Investigative site

    Linz, A-4020

  • Novartis Investigative Site

    Vienna, 1220

Other trials in Austria

Spain5 sites

  • Novartis Investigative Site

    Barcelona, 08014

  • Novartis Investigative Site

    Barcelona, 08028

  • Novartis Investigative Site

    Barcelona, 08035

  • Novartis Investigative Site

    Barcelona, 08190

  • Novartis Investigative Site

    Madrid, 28034

Other trials in Spain

Argentina4 sites

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1425CDC

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires F.D., C1429DUC

  • Novartis Investigative Site

    Ciudad Autonoma de Bs As, Buenos Aires, C1122AAL

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000BZL

Other trials in Argentina

About this study

Official title: A 76-week Prospective, Open-label, Multicenter Study to Evaluate the Long-term Effect of Rivastigmine Capsule and Transdermal Patch on Worsening of the Underlying Motor Symptoms of PD in Patients With Mild to Moderately Severe Dementia Associated With Parkinson's Disease (PDD)

The purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately severe dementia associated with PD.

Being tested
Rivastigmine capsule, Rivastigmine transdermal patch
Keywords
Parkinson's disease dementia, cholinesterase inhibitor, rivastigmine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivastigmine capsuleDrug

    Also called Exelon®

    Rivastigmine capsules orally twice a day. Target dose 12 mg/day.

  • Rivastigmine transdermal patchDrug

    Also called Exelon®

    Rivastigmine patch once a day in the morning, worn for 24 hours. Target dose 10 cm^2/day delivering 9.5 mg over a 24 hour period.

Study groups in NCT00623103
Study groupRoleWhat they receive
Rivastigmine capsuleExperimentalRivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally). The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
Receives: Drug: Rivastigmine capsule
Rivastigmine patchExperimentalRivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
Receives: Drug: Rivastigmine transdermal patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)

    The AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall)in each treatment group. The 95% CIs associated with the rates were also presented.

    Measured: 76 Weeks

  2. Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)

    The discontinuations due to these AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall) in each treatment group. The 95% CIs associated with these rates were also presented.

    Measured: 76 Weeks

Secondary outcomes (6)

  1. Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline

    Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). Part III records the motor examination in Items 18-31 rated on a scale of 0 to 4 with (0 being absent/ normal and 4 being the worse) for a total possible score of 0 to 56.

    Measured: From Baseline to Weeks 8, 16, 24, 52 and 76

  2. Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline

    Mattis DRS-2 is a measure of cognitive status. The total score is the sum of 5 subscale scores: Attention [0-37], Initiation/Perservation [0-37] (performing alternating movements), Construction [0-6] (copying designs), Conceptualization [0-39] (similarities) and Memory [0-25] (sentence recall, design recognition)for a total possible score of 0-144. Higher score is reflective of better cognitive function, lower scores associated with more pronounced cognitive deficit. The change from baseline was calculated such that a positive number indicates an improvement.

    Measured: From Baseline to Weeks 16, 24, 52 and 76

  3. Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline

    The Ten Point Clock Test measures executive functioning and visuospatial skills. Participants are asked to put numbers on the face of a clock and then make the clock read 10 minutes after 11. Points are awarded on a scale of 0 to 10 for spacing of specific numbers and the positions of the hands. The change from baseline was calculated such that a positive number indicates improvement.

    Measured: From Baseline to Weeks 16, 24, 52 and 76

  4. Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline

    The parameter for analysis was the change from baseline of total score of 10 items on the NPI scale (NPI-10). The total score is a sum of the 10 domains, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and all domains were equally weighted for total score(thus the range for the total score is 0 to 120 with 0 being completely healthy to 120 which is the worse score patient can get). The change from baseline was calculated such that a negative number indicates an improvement (symptom reduction).

    Measured: At Week 16, 24, 52 and 76 (or early discontinuation)

  5. Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline

    The 23 item caregiver-based ADL scale of the dementia Alzheimer's disease Cooperative Study-Activities of Daily Living (ADCS-ADL) was used for analysis. This is a caregiver rated questionnaire of 23 items, with possible scores over a range of 0-78, where 78 denote full functioning with no impairment. The total score was derived by adding up the item scores of the 23 items.

    The change from baseline was calculated such that a positive change indicates an improvement.

    Measured: From Baseline to Week 16, 24, 52 and 76 (or early discontinuation)

  6. UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation)

    Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). UPDRS Part V is assessed by the modified Hoehn and Yahr Staging Scale. The scale ranges from 0 (no signs of disease) to 5 (wheelchair bound or bedridden unless aided).

    Measured: From Baseline to Week 8, 16, 24, 52 and 76 (or early discontinuation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
583 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00623103
Sponsor's protocol ID
CENA713B2315
Status last verified
Oct 2011
First submitted
14 Feb 2008
Last updated
28 Nov 2011

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivastigmine capsule and Rivastigmine transdermal patch in people with Parkinson's Disease Dementia, run by Novartis at 127 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in Germany, United States, Italy, Canada, Netherlands and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) (time frame: 76 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00623103.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2011.

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