Parkinson's DiseaseNCT01646333
A Trial of Neurocognitive and Supportive Therapy Interventions for Individuals With Parkinson's Disease
A study testing Memory and Problem-Solving Intervention and Supportive Therapy in people with Parkinson's Disease and Mild Cognitive Impairment, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This randomized, controlled trial (RCT) evaluates the benefits of memory and problem solving training compared to supportive therapy in individuals with Parkinson's Disease with Mild Cognitive Impairment (MCI) and their support persons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease, Mild Cognitive Impairment
- What is being tested?
- Memory and Problem-Solving Intervention and Supportive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Clinical diagnosis of Mild Cognitive Impairment
Who cannot join
- Clinical diagnosis of Dementia
- Clinical diagnosis of other Parkinson's Disease-associated comorbid conditions (e.g., severe anxiety, depression, excessive daytime sleepiness, or psychosis) that significantly influence cognitive testing
Trial locations and contacts
1 site in 1 country.
United States1 site
VCU Parkinson's and Movement Disorders Center
Richmond, Virginia, 23230
About this study
Official title: A Randomized Controlled Trial of Neurocognitive and Supportive Therapy Interventions for Individuals With Parkinson's Disease
This randomized, controlled trial (RCT) evaluates the benefits of memory and problem solving training compared to supportive therapy in individuals with Parkinson's Disease with Mild Cognitive Impairment (MCI) and their support persons. Participants will be randomly assigned to receive memory and problem solving training or supportive therapy for 2-months. A 6-month follow up evaluation will establish if benefits remain over time. Impact of these therapies on thinking abilities, physical health, and patient and support person ratings of thinking skills, mood and quality of life will be evaluated. The memory and problem solving training is hypothesized to result in greater improvements and/or stability of function on neuropsychological tests of attention, working memory, learning, and memory skills compared to the supportive therapy condition. Both conditions are hypothesized to result in improved mood and quality of life ratings.
Results from this study will determine whether memory and problem solving therapies and supportive therapy are easily used by and beneficial for individuals with Parkinson's Disease and Mild Cognitive Impairment. If positive benefit is observed, information from this study will be used to further optimize these therapies for larger trials designed to evaluate the value of the therapies for individuals with Parkinson's Disease and their support persons.
Read the detailed description
The memory and problem solving training consists of a day calendar manual and note taking system and problem solving techniques. The supportive therapy offers patients and support persons the opportunity to discuss and reflect upon both Parkinson's Disease and non-Parkinson's Disease related problems.
- Conditions
- Parkinson's Disease, Mild Cognitive Impairment
- Being tested
- Memory and Problem-Solving Intervention, Supportive Therapy
- Keywords
- Parkinson Disease, Mild Cognitive Impairment, Cognition, Executive Function, Learning, Memory, Problem Solving
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory and Problem-Solving InterventionBehavioural
8 weekly 1 hour sessions of memory compensation and problem-solving strategies
Supportive TherapyBehavioural
8 weekly 1 hour sessions of non-directive supportive therapy.
| Study group | Role | What they receive |
|---|---|---|
| Supportive Therapy | Active comparator | The supportive therapy offers patients and support persons the opportunity to discuss and reflect upon both Parkinson's Disease and non-Parkinson's Disease related problems. Receives: Behavioral: Supportive Therapy |
| Memory and Problem-Solving Intervention | Experimental | The memory and problem solving training consists of a day calendar manual and note taking system and problem solving techniques. The neurocognitive memory intervention was adapted from a 6-week manualized day calendar and note taking system previously evaluated in an amnestic MCI sample and a brain tumor sample. The problem solving intervention was adapted from an originally 12-week intervention, which was later adapted into a 6-week brain tumor sample. Receives: Behavioral: Memory and Problem-Solving Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 10 Weeks
Change in California Verbal Learning Test-II Long Delay Free Recall Scaled Score from Baseline and 10 weeks
Measured: Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 10 weeks
Secondary outcomes (1)
Linear Analog Scale Assessment Overall Well Being Raw Score Change Over 10 Weeks
Change in Linear Analog Scale Assessment Overall Well Being Raw Score from Baseline and 10 weeks
Measured: Change from Baseline in Linear Analog Scale Assessment Overall Well Being Raw Score at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor
- Investigators
- Sarah K Lageman, Ph.D., Principal investigator, Virginia Commonwealth UniversityJames P Bennett, Jr., M.D., Ph.D., Study chair, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646333
- Sponsor's protocol ID
- PT107964
- Status last verified
- Jan 2016
- First submitted
- 13 Jul 2012
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Neurocognitive and Supportive Therapy Interventions for Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01646333
- Acronym / sponsor ID
- PT107964
- Conditions
- Parkinson's Disease, Mild Cognitive Impairment
- Keywords
- Parkinson Disease, Mild Cognitive Impairment, Cognition, Executive Function, Learning, Memory, Problem Solving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Jul 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, controlled trial (RCT) evaluates the benefits of memory and problem solving training compared to supportive therapy in individuals with Parkinson's Disease with Mild Cognitive Impairment (MCI) and their support persons. Participants will be randomly assigned to receive memory and problem solving training or supportive therapy for 2-months. A 6-month follow up evaluation will establish if benefits remain over time. Impact of these therapies on thinking abilities, physical health, and patient and support person ratings of thinking skills, mood and quality of life will be evaluated. The memory and problem solving training is hypothesized to result in greater improvements and/or stability of function on neuropsychological tests of attention, working memory, learning, and memory skills compared to the supportive therapy condition. Both conditions are hypothesized to result in improved mood and quality of life ratings.
Results from this study will determine whether memory and problem solving therapies and supportive therapy are easily used by and beneficial for individuals with Parkinson's Disease and Mild Cognitive Impairment. If positive benefit is observed, information from this study will be used to further optimize these therapies for larger trials designed to evaluate the value of the therapies for individuals with Parkinson's Disease and their support persons.
Detailed description
The memory and problem solving training consists of a day calendar manual and note taking system and problem solving techniques. The supportive therapy offers patients and support persons the opportunity to discuss and reflect upon both Parkinson's Disease and non-Parkinson's Disease related problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive Therapy | Active comparator | Behavioral: Supportive TherapyThe supportive therapy offers patients and support persons the opportunity to discuss and reflect upon both Parkinson's Disease and non-Parkinson's Disease related problems. |
| Memory and Problem-Solving Intervention | Experimental | Behavioral: Memory and Problem-Solving InterventionThe memory and problem solving training consists of a day calendar manual and note taking system and problem solving techniques. The neurocognitive memory intervention was adapted from a 6-week manualized day calendar and note taking system previously evaluated in an amnestic MCI sample and a brain tumor sample. The problem solving intervention was adapted from an originally 12-week intervention, which was later adapted into a 6-week brain tumor sample. |
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
- Clinical diagnosis of Mild Cognitive Impairment
Key exclusion criteria (2 listed)
- Clinical diagnosis of Dementia
- Clinical diagnosis of other Parkinson's Disease-associated comorbid conditions (e.g., severe anxiety, depression, excessive daytime sleepiness, or psychosis) that significantly influence cognitive testing
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 |
|---|---|---|
| Memory and Problem-Solving Intervention8 weekly 1 hour sessions of memory compensation and problem-solving strategies | Behavioural | Memory and Problem-Solving Intervention |
| Supportive Therapy8 weekly 1 hour sessions of non-directive supportive therapy. | Behavioural | Supportive Therapy |
Primary outcome
California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 10 Weeks
Time frame: Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 10 weeks
Change in California Verbal Learning Test-II Long Delay Free Recall Scaled Score from Baseline and 10 weeks
1 secondary outcome
Linear Analog Scale Assessment Overall Well Being Raw Score Change Over 10 Weeks
Time frame: Change from Baseline in Linear Analog Scale Assessment Overall Well Being Raw Score at 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
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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.
Sarah K Lageman, Ph.D. principal investigator
Virginia Commonwealth University
James P Bennett, Jr., M.D., Ph.D. study chair
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memory and Problem-Solving Intervention and Supportive Therapy in people with Parkinson's Disease and Mild Cognitive Impairment, run by Virginia Commonwealth 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 2 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 8 Jan 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 10 Weeks (time frame: Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 10 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 8 Jan 2016.