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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 below
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I am currently on carbidopa/levodopa medication.
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I am over 50 years old.
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My Parkinson's disease is not in the most advanced stage.
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I have been diagnosed with Parkinson's disease-related memory or thinking problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 26 weeks for reporting.

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 more

Side effects data

From 2016 Phase 3 trial • 613 Patients • NCT01968031
16%
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%
Hypertension
2%
Contusion
2%
Diarrhoea
2%
Paraesthesia
2%
Influenza
2%
Gait disturbance
2%
Somnolence
2%
Arthralgia
2%
Hallucination
2%
Anxiety
2%
Abnormal dreams
2%
Headache
1%
Cough
1%
Disturbance in attention
1%
Blood creatinine increased
1%
Myalgia
1%
Back pain
1%
Akinesia
1%
Hot flush
1%
Vision blurred
1%
Asthenia
1%
Depression
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
702 Previous Clinical Trials
22,886,889 Total Patients Enrolled
Matthew Barrett, MDPrincipal InvestigatorVirginia Commonwealth University

Media Library

Istradefylline (Adenosine A2A Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05333549 — Phase 2
Parkinson's Disease Research Study Groups: Usual care plus istradefylline
Parkinson's Disease Clinical Trial 2023: Istradefylline Highlights & Side Effects. Trial Name: NCT05333549 — Phase 2
Istradefylline (Adenosine A2A Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05333549 — Phase 2
~3 spots leftby Jul 2025
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