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Adenosine A2A Receptor Antagonist
Istradefylline for Parkinson's Disease with Cognitive Impairment
Phase 2
Recruiting
Led By Matthew Barrett, MD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Currently taking carbidopa/levodopa
Age greater than 50
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 26 weeks
Awards & highlights
Study Summary
This trial will test whether istradefylline can improve cognition in people with Parkinson's disease who also have cognitive impairment.
Who is the study for?
This trial is for individuals over 50 with Parkinson's disease who are experiencing cognitive impairment. They must be in the early to moderate stages of the disease, taking carbidopa/levodopa, and have stable medication doses. Those with dementia related to Lewy bodies, severe liver issues, or women who could become pregnant aren't eligible.Check my eligibility
What is being tested?
The study is testing whether a drug called Istradefylline can improve thinking and memory skills in people with Parkinson's disease who also have cognitive impairments.See study design
What are the potential side effects?
While not specified here, common side effects of Istradefylline may include nausea, dizziness, insomnia, constipation and potential worsening of parkinsonian symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently on carbidopa/levodopa medication.
Select...
I am over 50 years old.
Select...
My Parkinson's disease is not in the most advanced stage.
Select...
I have been diagnosed with Parkinson's disease-related memory or thinking problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 26 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in executive function - Card Sort test
Secondary outcome measures
Change in Parkinson disease stage
Change in Parkinson's health status
Change in Schwab and England ADL score
+12 moreSide effects data
From 2016 Phase 3 trial • 613 Patients • NCT0196803116%
Dyskinesia
9%
Fall
6%
Nausea
4%
Dizziness
4%
Constipation
4%
Fatigue
3%
Urinary tract infection
3%
Vomiting
3%
Insomnia
3%
On and off phenomenon
2%
Contusion
2%
Hypertension
2%
Diarrhoea
2%
Influenza
2%
Gait disturbance
2%
Paraesthesia
2%
Somnolence
2%
Arthralgia
2%
Hallucination
2%
Anxiety
2%
Abnormal dreams
2%
Headache
1%
Cough
1%
Disturbance in attention
1%
Blood creatinine increased
1%
Back pain
1%
Myalgia
1%
Depression
1%
Vision blurred
1%
Asthenia
1%
Akinesia
1%
Hot flush
1%
Anaemia
1%
Orthostatic hypotension
1%
Vertigo
1%
Sinusitis
1%
Head injury
1%
Blood pressure increased
1%
Blood uric acid increased
1%
Neck pain
1%
Presyncope
1%
Rib fracture
1%
Excoriation
1%
Tinnitus
1%
Weight decreased
1%
Amylase increased
1%
Abdominal distension
1%
Dental caries
1%
Abdominal pain upper
1%
Oedema peripheral
1%
Rhinitis
1%
Nasopharyngitis
1%
Upper respiratory tract infection
1%
Bronchitis
1%
Cystitis
1%
Road traffic accident
1%
Eosinophil count increased
1%
Blood creatine phosphokinase increased
1%
Pain in extremity
1%
Musculoskeletal pain
1%
Muscle spasms
1%
Restless legs syndrome
1%
Parkinson's disease
1%
Micturition urgency
1%
Rash
1%
Freezing phenomenon
1%
Dystonia
1%
Leukopenia
1%
Tremor
1%
Rapid eye movements sleep abnormal
1%
Lipase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Istradefylline 40 mg/Day
Placebo
Istradefylline 20 mg/Day
Trial Design
1Treatment groups
Experimental Treatment
Group I: Usual care plus istradefyllineExperimental Treatment1 Intervention
Participants will receive usual care, and in addition, will be asked to take istradefylline daily for 26 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Istradefylline
2014
Completed Phase 3
~1120
Find a Location
Who is running the clinical trial?
Kyowa Kirin, Inc.Industry Sponsor
47 Previous Clinical Trials
5,711 Total Patients Enrolled
Virginia Commonwealth UniversityLead Sponsor
699 Previous Clinical Trials
22,885,035 Total Patients Enrolled
Matthew Barrett, MDPrincipal InvestigatorVirginia Commonwealth University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My Parkinson's medication has been the same for the last 4 weeks.I am currently on carbidopa/levodopa medication.My liver is not working well.I am over 50 years old.My Parkinson's disease is not in the most advanced stage.I have been diagnosed with Parkinson's disease-related memory or thinking problems.I experience significant involuntary movements.I was diagnosed with dementia around the same time or before I showed signs of Parkinson's.My cholinesterase inhibitor dose has been stable for 8 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care plus istradefylline
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have been enlisted for this experiment?
"That is correct. Clinicaltrials.gov suggests that this medical experiment, which was first listed on July 18th 2022, is presently enrolling patients and required 10 participants from 1 particular location."
Answered by AI
What potential risks does Istradefylline pose to those who take it?
"Istradefylline's safety rating is 2, as there is some evidence to suggest its safety but no information yet on how effective it may be."
Answered by AI
Are there current opportunities for participants to join this medical experiment?
"Affirmative. The clinicaltrials.gov webpage reveals that this investigation is actively recruiting participants, having first been posted on 18 July 2022 and last updated on 10 August 2022. In total, they are looking to enrol 10 people at a single trial site."
Answered by AI
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