Parkinson's DiseasePhase 1NCT04449484
Multiple Ascending Dose Study of MEDI1341 in Patients With Parkinson's Disease
A Phase 1 study testing MEDI1341 in people with Parkinson's Disease, run by AstraZeneca at 5 sites in United States.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled study of multiple ascending iv doses of MEDI341 in male and female subjects with Parkinson's Disease. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- MEDI1341
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 5 sitesUnited States
- Study dates
- 4 Aug 2020to 5 Jan 2022
- Phase
- Phase 1
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be aged 40 to 85 years, inclusive, on the day of randomization.
- Meet criteria for a diagnosis of mild-to-moderate idiopathic PD according to the United Kingdom Parkinson's Disease Society Brain Bank criteria (Hughes et al 1992)
- PD should be stage 1 to 3 using the Hoehn and Yahr scale as modified (Goetz et al 2004).
- Subjects receiving medications for PD should have been on a stable dosing regimen of their medication(s) for ≥ 1 month before randomization, with no expectation of a need to change the medications or dosing regimen for the duration of the study, barring unforeseen circumstances. (For subjects who are not currently receiving medications to treat PD, there should be no expectation of a need to initiate these for the duration of the study).
- Subjects must have a body weight of 45 to 120 kg, inclusive, and a body mass index of 18 to 34 kg/m2, inclusive at screening and at check-in for the first infusion.
- Subjects may be male or female. Female subjects must of non-childbearing potential (postmenopausal and/or surgically sterile.
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- Postmenopausal women must have had ≥ 12 months of spontaneous amenorrhea (with a follicle-stimulating hormone [FSH] concentration ≥ 26 mIU/mL in women ≤ 60 years of age; women > 60 years of age do not require an FSH test) and must have had a negative serum pregnancy test result at screening.
- Surgically sterile women are defined as those who have had a hysterectomy, bilateral ovariectomy (oophorectomy), salpingectomy, or bilateral tubal ligation. Women who are surgically sterile must provide documentation of the procedure by an operative report, ultrasound, or other verifiable medical documentation.
- Men who are biologically capable of fathering children must agree and commit to use an adequate form of double-barrier contraception for the duration of the treatment period and for 5 half lives (100 days) after the last administration of study intervention. A male subject is considered capable of fathering children even if his sexual partner is sterile or using contraceptives.
- Men who are biologically capable of fathering children must also agree to refrain from sperm donation for the duration of the treatment period and for 5 half-lives or 90 days (whichever is longer) after the last administration of study intervention.
- Subjects must, in the investigator's opinion, understand the nature of the study and must provide signed and dated written informed consent before the conduct of any study-related procedures.
- Subjects must, in the opinion of the investigator, be able to participate in all scheduled evaluations, likely to be compliant, and likely to complete all required tests, including magnetic resonance imaging (MRI) brain scans and lumbar punctures (LPs). (Note: The investigator should assess the physical and functional needs of the subject at screening, as participation in the study may be contingent upon the availability and willingness of a caregiver to attend with the subject at all study visits.)
- Subjects must be able to read, write, and speak fluently in English and/or Spanish.
- Subjects must agree not to post any personal medical data related to the study or information related to the study on any website or social media site (eg, Facebook, Twitter, Instagram, etc) until the study has been completed.
- Subjects must have a MoCA total score of ≥ 24.
Who cannot join
- In the opinion of the investigator, a recent clinically significant illness (other than PD), infection, medical/surgical procedure, or significant trauma within 30 days prior to screening, or between screening and randomization, that is likely to deteriorate, compromise the subject's safety or ability to complete the study, or compromise the interpretation of the study results (Note: a history of coronavirus disease 2019 [COVID 19] infection with unresolved medical sequelae would be considered exclusionary.)
- Presence of a serious or unstable clinically significant illness, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic or autoimmune disease (eg, multiple sclerosis), hematologic or other major disease, which, in the judgment of the investigator, is poorly controlled or otherwise likely to deteriorate, compromise the subject's safety or ability to complete the study, or compromise the interpretation of the study results
- Significant neurological disease affecting the CNS (other than PD) that, in the opinion of the investigator, may affect motor function or the ability to complete the study, including but not limited to progressive supranuclear palsy, multiple system atrophy (MSA; including MSA-P and MSA-C or other MSA terminology: striatonigral degeneration, olivopontocerebellar atrophy or autonomic failure), postencephalitic parkinsonism, metabolic diseases with parkinsonian signs and symptoms (eg, Wilson disease, manganese exposure) or other secondary forms of Parkinsonism, and ischemic or traumatic brain injury (including multiple episodes of head trauma, or head trauma resulting in protracted loss of consciousness within the 5 years prior to screening or between screening and randomization)
- Brain MRI scan that shows clinically significant evidence of malignant, ischemic, demyelinating, structural, or degenerative brain disease or has findings that compromise the safety of LP
- Has undergone surgery for the treatment of PD (eg, pallidotomy, deep brain stimulation, fetal tissue transplantation) or has undergone any other brain surgery at any time, even for non-PD conditions
- History of epilepsy or seizures, except febrile childhood seizures
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- History of transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to screening or between screening and randomization
- Presence of any psychiatric disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V; APA 2013) or symptom if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of the study results, affect motor function assessment, or affect the subject's ability to complete the study
- A diagnosis of intellectual disability (intellectual developmental disorder) or mental retardation, or significant inherited cognitive impairment
- Suicidality, represented by answering "yes" to Question 4 or Question 5 on the C SSRS, indicating active suicidal ideation with any intent to act, during the subject's lifetime, as assessed at screening, or between screening and randomization
- Suicidal behavior such that a determination of "yes" is made on the Suicidal Behavior section of the C SSRS for "Actual Attempt," "Interrupted Attempt," "Aborted Attempt," or "Preparatory Acts or Behavior," during the subject's lifetime, as assessed at screening, or between screening and randomization
- History of alcohol or drug abuse or dependence (except nicotine dependence), as defined by the DSM-V, within 2 years prior to screening or between screening and randomization
- Within 1 year prior to screening, any of the following: myocardial infarction; hospitalization for congestive heart failure; hospitalization for, or symptoms of unstable angina; unexplained syncope
- Moderate or severe congestive heart failure, or known ejection fraction < 40%
- Known significant structural heart disease (eg, significant valvular disease, hypertrophic cardiomyopathy) that is considered likely to lead to a deterioration of cardiac function over the course of the study
- History of cancer within 5 years prior to screening or between screening and randomization, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin
- History of allergy/hypersensitivity to immunizations or immunoglobulins
- Any condition that, in the opinion of the investigator or medical monitor, makes the subject unsuitable for the study
- Requires treatment with another monoclonal antibody
- Use of any investigational medicine, device, or biologic within 3 months or 5 half-lives of that intervention (whichever is longer) prior to screening
- Previous allogeneic bone marrow or stem cell transplant
- Use of typical or atypical antipsychotic medication, or other medication with dopamine antagonist properties (eg, metoclopramide, domperidone), within 6 months prior to randomization
- Use of immunosuppressive medication within 6 months prior to randomization. (Note: Inhaled and topical corticosteroids are permitted. Low-dose systemic corticosteroids [< 10 mg per day prednisone or equivalent], for autoimmune disease that is considered to be quiescent, in remission, or otherwise well controlled are permitted). Other immunosuppressive drugs and biologics are contraindicated.
- Received non-leukocyte depleted whole blood transfusion within 6 months prior to screening
- Received any commercially available vaccine within 30 days prior to randomization. (Note: for COVID-19 vaccines authorized by the FDA for emergency use, this time frame applies from last vaccination or booster dose, whichever is required to consider vaccination complete in line with applicable guidance.)
- Participation in another study investigating:
- Active or passive immunization against α synuclein for PD, at any time prior to screening, or
- Immunoglobulin G therapy within 6 months before screening
- Any clinically significant abnormality as determined by investigator at screening or between screening and randomization in physical examination, vital signs, ECG, or clinical laboratory test results that may compromise the subject's safety or ability to complete the study or compromise the interpretation of the study results
- Presence of any of the following MRI contraindications: pacemaker; cardiac defibrillator; spinal cord or vagus nerve stimulator; aneurysm clip; artificial heart valve; recent (within one year) coronary or carotid stent; ear implant; CSF shunt; other implanted medical device (eg, insulin pump); metal fragments or foreign objects in the eyes, skin, or body; claustrophobia that would contraindicate a brain MRI scan
- Brain MRI findings (or historical radiologic reports, if available) that show evidence of clinically significant structural brain disease which, in the opinion of the investigator, contraindicates performance of LP
- Any spinal abnormality or other aspects (eg, tattoos) or other clinical findings (papilledema seen with ophthalmoscopy) that may complicate or contraindicate LP, as judged by the investigator
- Ophthalmic abnormalities. The following are considered exclusionary:
- Congenital or acquired ophthalmic conditions (primary or secondary) that are considered poorly controlled within the last 12 months prior to screening, with or without treatment, or otherwise expected to lead to significant deterioration in visual acuity in the next 6 months after randomization
- Specific ophthalmic conditions:
- Current or past history of inflammation affecting the uveal tract or sclera ii. Diabetic retinopathy iii. Neovascular or exudative (wet) form of age-related macular degeneration iv. Active central serous retinopathy (central serous chorioretinopathy) v. Subjects with active autoimmune disease vi. Subjects taking immunosuppressive drugs (other than low doses of systemic steroids [< 10 mg per day of prednisone equivalent], for autoimmune disease that is considered to be inactive, in remission, or otherwise well-controlled). Other immunosuppressive drugs are contraindicated.
- Mature cataracts (Grade ≥ 4 per the Lens Opacities Classification System III) or lower grade cataracts that are otherwise considered by the examining ophthalmologist to prevent adequate examination of the uveal tract or posterior ocular segment. (Note: Previous cataract surgery or an age-related cataract with age-appropriate lens opacification and no other important identified secondary causes [eg, diabetes, corticosteroids, vitamin deficiencies, trauma, radiation, or systemic fluid and electrolyte disturbances] is not necessarily exclusionary.)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentrations >1.5 × the upper limit of normal (ULN) at screening, or between screening and baseline
- Estimated creatinine clearance < 50 mL/min or creatinine > 1.5 × ULN at screening
- Clinically significant vital sign abnormalities at screening or on Day 1, defined as (a) systolic blood pressure ≥ 160 mmHg, (b) diastolic blood pressure ≥ 90 mmHg (blood pressure assessed at rest; may be repeated up to 3 times), or (c) pulse rate < 45 or > 100 beats per minute (at rest)
- Clinically significant abnormality in ECG rhythm, conduction or morphology at screening or between screening and randomization, including but not limited to:
- Clinically significant PR (PQ) interval prolongation (PR > 220 msec)
- Intermittent second or third degree atrioventricular (AV) block (AV block II Mobitz Type I, Wenckebach, while asleep or in deep rest is not exclusionary)
- Bundle branch block or intraventricular conduction delay with QRS interval duration ≥ 120 msec
- A Fridericia's corrected QT (QTcF) interval measurement > 470 msec, or a shortened QTcF < 340 msec, at screening or between screening and randomization; or a family history of long or short QT syndrome
- Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies, with relevant confirmatory testing conducted, where applicable, in accordance with Centers for Disease Control and Prevention guidance for HIV and viral hepatitis
- Current blood clotting or bleeding disorder, including clinically significant abnormal findings in laboratory tests of coagulation
- Poor venous access, such that IV drug delivery or PK/safety blood sampling would be difficult
- Donation of blood or plasma within 2 months prior to screening and until 2 months after the final follow-up visit
- A positive serum pregnancy test result at screening or prior to randomization
- Urine drug screen positive for a drug of abuse (except for permitted, prescribed opiates and /or benzodiazepines). A urine drug screen positive for cannabinoids is exclusionary unless there is a documented legitimate medical reason for the subject's cannabinoid use (eg, chronic pain) or the investigator and medical monitor agree that the subject can abstain from use for the duration of the study.
- Current employment by the sponsor (AstraZeneca) or by a contract research organization or clinical study site participating in this study, or a first-degree relative of an AstraZeneca employee or of an employee at a participating contract research organization or clinical study site
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Research Site
Atlanta, Georgia, 30331
Research Site
Farmington Hills, Michigan, 48334
Research Site
Hallandale, Florida, 33009
Research Site
Long Beach, California, 90806
Research Site
Spokane, Washington, 99202
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of MEDI1341 in Subjects With Parkinson's Disease
This is a multicenter, randomized, double-blind, placebo-controlled study of multiple ascending iv doses of MEDI341 in male and female subjects with Parkinson's Disease.
Read the detailed description
The study will include up to 3 cohorts, with 12 subjects in each, for a total of up to 36 randomised subjects.
The study comprises a screening period of up to 49 days, an 8-week double-blind treatment period, and a 13-week follow-up period. Each subject will receive three 60 minute iv infusions of MEDI1341 or placebo during the 8-week treatment period, with 4 weeks between infusions. The overall study duration (enrolment, treatment, and follow-up periods) will be up to 28 weeks per subject.
A Dose Escalation Committee will review data from each cohort to allow progression to the next higher dose cohort in the study.
- Conditions
- Parkinson's Disease
- Being tested
- MEDI1341, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI1341Drug
Also called TAK-341
Intravenous infusion over 60 minutes
PlaceboOther
Intravenous infusion over 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| MEDI1341 | Experimental | 3 doses given at 4 week intervals Receives: Drug: MEDI1341 |
| Placebo | Placebo comparator | 3 doses given at 4 week intervals Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Incidence, Nature, Severity and Seriousness of adverse events from screening
Measured: 28 weeks
Vital Signs
Change from baseline in Blood Pressure measured in millimetres of Mercury
Measured: 21 weeks
Oral Body Temperature
Change from baseline in body temperature measured in degrees Celcius
Measured: 21 weeks
Body Weight
Change from baseline measured in Kilograms
Measured: 21 weeks
Safety Laboratory Tests
Incidence from baseline in abnormal laboratory test results
Measured: 21 weeks
Electrocardiograms
Change from baseline in ECG rythm
Measured: 21 weeks
Ophthalmic assessments
Incidence from baseline in abnormal ocular findings
Measured: 21 weeks
Suicidal Ideation
Evaluation of presence or absence of suicidal ideation as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: 21 weeks
Cognitive impairment
Change from baseline in the total score of the Montreal Cognitive assessment; a 30-point test (the higher the score, the better the cognition)
Measured: 21 weeks
Electrocardiograms
Change from baseline in ECG heart rate
Measured: 21 weeks
Electrocardiograms
Change from baseline in ECG conduction
Measured: 21 weeks
Electrocardiograms
Change from baseline in ECG PR interval
Measured: 21 weeks
Electrocardiograms
Change from baseline in ECG QRS interval
Measured: 21 weeks
Electrocardiograms
Change from baseline in ECG RR interval
Measured: 21 weeks
Electrocardiograms
Change from baseline in ECG QT interval
Measured: 21 weeks
Electrocardiograms
Change from baseline in ECG QTcF interval
Measured: 21 weeks
Suicidal Behaviour
Evaluation of presence or absence of suicidal behaviour as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start4 Aug 2020
- Primary completion5 Jan 2022
- Study completion5 Jan 2022
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 AstraZenecaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects are randomised to one of two groups within a cohort of 12 subjects (N=9 MEDI1341; N=3 Placebo)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda
- Responsible party
- Sponsor
- Investigators
- Beth E. Safirstein, MD, Principal investigator, MD Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449484
- Sponsor's protocol ID
- D6340C00002
- Status last verified
- May 2022
- First submitted
- 23 Apr 2019
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymised individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of MEDI1341 in Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04449484
- Acronym / sponsor ID
- D6340C00002
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Takeda
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 26 Jun 2020 (actual)
- 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 is a multicenter, randomized, double-blind, placebo-controlled study of multiple ascending iv doses of MEDI341 in male and female subjects with Parkinson's Disease.
Detailed description
The study will include up to 3 cohorts, with 12 subjects in each, for a total of up to 36 randomised subjects.
The study comprises a screening period of up to 49 days, an 8-week double-blind treatment period, and a 13-week follow-up period. Each subject will receive three 60 minute iv infusions of MEDI1341 or placebo during the 8-week treatment period, with 4 weeks between infusions. The overall study duration (enrolment, treatment, and follow-up periods) will be up to 28 weeks per subject.
A Dose Escalation Committee will review data from each cohort to allow progression to the next higher dose cohort in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects are randomised to one of two groups within a cohort of 12 subjects (N=9 MEDI1341; N=3 Placebo)
| Arm | Type | Receives |
|---|---|---|
| MEDI1341 | Experimental | Drug: MEDI13413 doses given at 4 week intervals |
| Placebo | Placebo comparator | Other: Placebo3 doses given at 4 week intervals |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects must be aged 40 to 85 years, inclusive, on the day of randomization.
- Meet criteria for a diagnosis of mild-to-moderate idiopathic PD according to the United Kingdom Parkinson's Disease Society Brain Bank criteria (Hughes et al 1992)
- PD should be stage 1 to 3 using the Hoehn and Yahr scale as modified (Goetz et al 2004).
- Subjects receiving medications for PD should have been on a stable dosing regimen of their medication(s) for ≥ 1 month before randomization, with no expectation of a need to change the medications or dosing regimen for the duration of the study, barring unforeseen circumstances. (For subjects who are not currently receiving medications to treat PD, there should be no expectation of a need to initiate these for the duration of the study).
- Subjects must have a body weight of 45 to 120 kg, inclusive, and a body mass index of 18 to 34 kg/m2, inclusive at screening and at check-in for the first infusion.
Key exclusion criteria (52 listed)
- In the opinion of the investigator, a recent clinically significant illness (other than PD), infection, medical/surgical procedure, or significant trauma within 30 days prior to screening, or between screening and randomization, that is likely to deteriorate, compromise the subject's safety or ability to complete the study, or compromise the interpretation of the study results (Note: a history of coronavirus disease 2019 [COVID 19] infection with unresolved medical sequelae would be considered exclusionary.)
- Presence of a serious or unstable clinically significant illness, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic or autoimmune disease (eg, multiple sclerosis), hematologic or other major disease, which, in the judgment of the investigator, is poorly controlled or otherwise likely to deteriorate, compromise the subject's safety or ability to complete the study, or compromise the interpretation of the study results
- Significant neurological disease affecting the CNS (other than PD) that, in the opinion of the investigator, may affect motor function or the ability to complete the study, including but not limited to progressive supranuclear palsy, multiple system atrophy (MSA; including MSA-P and MSA-C or other MSA terminology: striatonigral degeneration, olivopontocerebellar atrophy or autonomic failure), postencephalitic parkinsonism, metabolic diseases with parkinsonian signs and symptoms (eg, Wilson disease, manganese exposure) or other secondary forms of Parkinsonism, and ischemic or traumatic brain injury (including multiple episodes of head trauma, or head trauma resulting in protracted loss of consciousness within the 5 years prior to screening or between screening and randomization)
- Brain MRI scan that shows clinically significant evidence of malignant, ischemic, demyelinating, structural, or degenerative brain disease or has findings that compromise the safety of LP
- Has undergone surgery for the treatment of PD (eg, pallidotomy, deep brain stimulation, fetal tissue transplantation) or has undergone any other brain surgery at any time, even for non-PD conditions
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 |
|---|---|---|
| MEDI1341Also: TAK-341Intravenous infusion over 60 minutes | Drug | MEDI1341 |
| PlaceboIntravenous infusion over 60 minutes | Other | Placebo |
Primary outcome
Adverse Events
Time frame: 28 weeks
Incidence, Nature, Severity and Seriousness of adverse events from screening
Vital Signs
Time frame: 21 weeks
Change from baseline in Blood Pressure measured in millimetres of Mercury
Oral Body Temperature
Time frame: 21 weeks
Change from baseline in body temperature measured in degrees Celcius
Body Weight
Time frame: 21 weeks
Change from baseline measured in Kilograms
Safety Laboratory Tests
Time frame: 21 weeks
Incidence from baseline in abnormal laboratory test results
Electrocardiograms
Time frame: 21 weeks
Change from baseline in ECG rythm
Ophthalmic assessments
Time frame: 21 weeks
Incidence from baseline in abnormal ocular findings
Suicidal Ideation
Time frame: 21 weeks
Evaluation of presence or absence of suicidal ideation as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
Cognitive impairment
Time frame: 21 weeks
Change from baseline in the total score of the Montreal Cognitive assessment; a 30-point test (the higher the score, the better the cognition)
Electrocardiograms
Time frame: 21 weeks
Change from baseline in ECG heart rate
Electrocardiograms
Time frame: 21 weeks
Change from baseline in ECG conduction
Electrocardiograms
Time frame: 21 weeks
Change from baseline in ECG PR interval
Electrocardiograms
Time frame: 21 weeks
Change from baseline in ECG QRS interval
Electrocardiograms
Time frame: 21 weeks
Change from baseline in ECG RR interval
Electrocardiograms
Time frame: 21 weeks
Change from baseline in ECG QT interval
Electrocardiograms
Time frame: 21 weeks
Change from baseline in ECG QTcF interval
Suicidal Behaviour
Time frame: 21 weeks
Evaluation of presence or absence of suicidal behaviour as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
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 3 Jun 2022.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymised individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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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.
Beth E. Safirstein, MD principal investigator
MD Clinical
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI1341 in people with Parkinson's Disease, run by AstraZeneca at 5 sites 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 15 inclusion and 52 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 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adverse Events (time frame: 28 weeks). The study lists 17 primary outcomes in all. 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 3 Jun 2022.