Parkinson's DiseasePhase 4NCT01340885
Cognitive Decline in Non-demented PD
A Phase 4 study testing Strattera and Exelon in people with Parkinson's Disease, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to determine the relationship between attention and quality of life and how rivastigmine and atomoxetine alter attention in non-demented persons with Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Strattera and Exelon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2013
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson's disease
- Respond to levodopa therapy
Who cannot join
- Dementia
- Psychiatric disorders including anxiety disorders, dissociative disorders, mood disorders, schizophrenia and related disorders, or ADD/ADHD
- Any clinically unstable disease such as cancer, HIV/AIDS, heart condition, liver disease, kidney or renal failure or others that might require hospitalization
- Evidence for another neurological disease (history of seizures, Alzheimer disease, multiple sclerosis or other movement disorders);
- Currently using any of the study drugs;
- Colorblindness
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Cognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot Study
The purpose of this study is to determine the relationship between attention and quality of life and how rivastigmine and atomoxetine alter attention in non-demented persons with Parkinson's disease (PD).
Read the detailed description
Cognitive dysfunction can occur in early stage of Parkinson's disease (PD) and increases as PD progresses. Attention deficits in PD patients with dementia strongly predict the impairment of their daily living activities.
Previous studies have shown that atomoxetine improves PD executive dysfunction and rivastigmine improves attention deficits in PD patients with dementia without worsening the motor symptoms.
The aim of this study is to examine the effect of atomoxetine and rivastigmine on attention and quality of life in PD patients without disabling cognitive impairment.
- Conditions
- Parkinson's Disease
- Being tested
- Strattera, Exelon, Placebo
- Keywords
- attention, mild cognitive impairment, dementia
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StratteraDrug
Also called atomoxetine
10-30 mg b.i.d. for 6 weeks
ExelonDrug
Also called rivastigmine
1.5-4.5 mg b.i.d. for 6 weeks
PlaceboOther
Also called sugar pill
2-6 pills for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| atomoxetine | Active comparator | Strattera 10-30 mg b.i.d. Receives: Drug: Strattera |
| rivastigimine | Active comparator | Exelon 1.5-4.5 mg b.i.d. Receives: Drug: Exelon |
| Placebo | Placebo comparator | sugar pill Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention Network Effects
Measured: 6 weeks
Secondary outcomes (5)
Quality of Life
PDQ-39
Measured: 6 weeks
Stroop Color Word Test
Measured: 6 weeks
Fatigue
Measured: 6 weeks
Depression
Measured: 6 weeks
Daytime Sleepiness
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Jau-Shin Lou, Oregon Health and Science University
- Investigators
- Jau-Shin Lou, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340885
- Sponsor's protocol ID
- PANUC - Lou
- Other IDs
- 5P50NS062684-02
- Status last verified
- Jun 2020
- First submitted
- 19 Apr 2011
- Last updated
- 7 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot Study
- ClinicalTrials.gov ID
- NCT01340885
- Acronym / sponsor ID
- PANUC - Lou
- Conditions
- Parkinson's Disease
- Keywords
- attention, mild cognitive impairment, dementia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 Apr 2011 (estimated)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the relationship between attention and quality of life and how rivastigmine and atomoxetine alter attention in non-demented persons with Parkinson's disease (PD).
Detailed description
Cognitive dysfunction can occur in early stage of Parkinson's disease (PD) and increases as PD progresses. Attention deficits in PD patients with dementia strongly predict the impairment of their daily living activities.
Previous studies have shown that atomoxetine improves PD executive dysfunction and rivastigmine improves attention deficits in PD patients with dementia without worsening the motor symptoms.
The aim of this study is to examine the effect of atomoxetine and rivastigmine on attention and quality of life in PD patients without disabling cognitive impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| atomoxetine | Active comparator | Drug: StratteraStrattera 10-30 mg b.i.d. |
| rivastigimine | Active comparator | Drug: ExelonExelon 1.5-4.5 mg b.i.d. |
| Placebo | Placebo comparator | Other: Placebosugar pill |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Parkinson's disease
- Respond to levodopa therapy
Key exclusion criteria (6 listed)
- Dementia
- Psychiatric disorders including anxiety disorders, dissociative disorders, mood disorders, schizophrenia and related disorders, or ADD/ADHD
- Any clinically unstable disease such as cancer, HIV/AIDS, heart condition, liver disease, kidney or renal failure or others that might require hospitalization
- Evidence for another neurological disease (history of seizures, Alzheimer disease, multiple sclerosis or other movement disorders);
- Currently using any of the study drugs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StratteraAlso: atomoxetine10-30 mg b.i.d. for 6 weeks | Drug | atomoxetine |
| ExelonAlso: rivastigmine1.5-4.5 mg b.i.d. for 6 weeks | Drug | rivastigimine |
| PlaceboAlso: sugar pill2-6 pills for 6 weeks | Other | Placebo |
Primary outcome
Attention Network Effects
Time frame: 6 weeks
5 secondary outcomes
Quality of Life
Time frame: 6 weeks
Stroop Color Word Test
Time frame: 6 weeks
Fatigue
Time frame: 6 weeks
Depression
Time frame: 6 weeks
Daytime Sleepiness
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jau-Shin Lou, MD, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Strattera and Exelon in people with Parkinson's Disease, run by Oregon Health and Science University at 1 site in United States.
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 2 inclusion and 6 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 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 7 Jul 2020). 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?
Attention Network Effects (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2020.