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Parkinson DiseasePhase 2NCT04305002

Exenatide Treatment in Parkinson's Disease

A Phase 2 study testing Exenatide in people with Parkinson Disease, run by Center for Neurology, Stockholm at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The development of a disease-modifying therapy that delays, reverses or stops the symptom progression remains the most important unmet goal in the treatment of Parkinson's disease (PD). Read more about this study

Who is it for?
Ages 25 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
Exenatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteSweden
Study dates
21 Jan 2020to 10 Oct 2023
Phase
Phase 2
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 25 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of clinically probable Parkinson's disease according to the MDS clinical diagnostic criteria for PD
  • Males or Females
  • Hoehn and Yahr stage ≤ 2 in the ON medication state. This implies that all patients will be mobile without assistance during their best "ON" medication periods.
  • Patients are on levodopa treatment.
  • No need for extended treatment adjustment, no significant motor fluctuations during the last year.
  • All patients will be ≥25 and ≤80 years of age
  • Ability to self-administer, or to arrange carer administration of the trial drug.
  • Signed informed consent to participate in the trial.

Who cannot join

  • Atypical or other causes of parkinsonism. Patients with suspected Multiple System Atrophy, Progressive Supranuclear Palsy, drug-induced parkinsonism, vascular parkinsonism, dystonic or essential tremor will not be included in the trial.
  • Prior intra-cerebral surgical intervention for Parkinson's disease. Patients who have previously undergone Deep Brain Stimulation, intra-cerebral administration of growth factors, gene therapy or cell therapies will not be eligible.
  • Already actively participating in a trial of a device, drug or surgical treatment for Parkinson's disease.
  • Previous exposure to Exenatide.
  • Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol/FDG-PET acquisition.
  • Patients with body mass index below 18.5. Exenatide causes weight loss, and individuals with already low BMI will not be eligible.
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  • Patients with diabetes mellitus type 1.
  • Patients with prediabetes (HbA1c at screening 42-47 mmol/mol), or T2DM (known diagnosis, ongoing antidiabetic treatment or HbA1c > 47 mmol-mol and fasting plasma glucose > 7.0 mmol/L at screening).
  • History of pancreatitis. Baseline serum amylase value should be within the laboratory normal range +/- 20 percent.
  • Severe gastrointestinal disease including gastroparesis.
  • History of alcoholism.
  • History of severe cardiac disease.
  • History of pancreas cancer.
  • History or suspicion of thyroid cancer. Undiagnosed neck lump, hoarse voice, or difficulty swallowing not attributable to PD.
  • Personal or family history of medullary thyroid cancer.
  • Patients with Multiple Endocrine Neoplasia 2 (MEN2) syndrome.
  • End stage renal disease or creatinine clearance < 50 ml/min.
  • Hyperlipidaemia. A lipid profile will be tested at the screening visit. Cholesterol or Triglyceride levels greater than 2 x the upper limit of normal will raise suspicion of a familial or acquired hyperlipidaemia and will prompt referral to a relevant specialist for investigation and treatment.
  • Concurrent treatment with warfarin.
  • Concurrent severe depression, defined as MADRS score 16.
  • Concurrent dementia, defined as Mini-Mental State Examination (MMSE) < 22.
  • Pregnancy and Breastfeeding.
  • There are no safety data regarding Exenatide use in pregnancy. Women of childbearing potential should only be included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test, and will be asked at each visit to confirm regular use of an effective method of contraception. Those who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and until the end of the relevant systemic exposure period (i.e. 10 weeks after the last dose of study drug) will not be eligible. The following birth control methods are considered to be acceptable: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, and sexual abstinence.
  • Known hypersensitivity or allergy or intolerance to GLP-1.
  • Known hypersensitivity to Exenatide or any of its excipients.
  • Potential participants who lack the capacity to give informed consent
  • Any medical, psychiatric or other condition which in the investigator's opinion compromises the potential participant's ability to participate in the trial.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Academic Specialist Center, Center for Neurology, SLSO

    Stockholm

Other trials in Sweden

About this study

Official title: Effect of Exenatide on Disease Progression in Early Parkinson's Disease

The development of a disease-modifying therapy that delays, reverses or stops the symptom progression remains the most important unmet goal in the treatment of Parkinson's disease (PD). Apart from its glucose lowering effect, glucagon-like peptide-1 (GLP-1) receptor stimulation has been investigated in animal models of PD and shown to increase neurogenesis, to arrest and possible reverse nigrostriatal damage, and to protect dopaminergic neurons from neurodegeneration. Exenatide is a synthetic analogue of human GLP-1, resistant to the metabolic processes that degrade it in its naturally occurring form. Results from a recent randomised, double-blind, placebo-controlled trial in PD showed that patients in active treatment for one year were improved compared to the placebo arm with regard to their performance in Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor subscale in the practically defined OFF medication state.

The aim of this trial is to investigate the effect of Exenatide, 2 mg, subcutaneous injection, once weekly on disease progression represented by the change in longitudinal Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose (FDG-PET) in individual PD subjects, and to identify an Exenatide-related pattern in FDG-PET that will provide insight into the treatment-effect in the brain. The investigators chose the standard regimen prescribed in Type 2 Diabetes Mellitus (T2DM) and the regimen used in a recent trial in PD. The treatment period will be 18 months, and patients will be randomly assigned to either active treatment or placebo. Patients with PD diagnosis, stable on medication during the last year, and Hoehn and Yahr stage 2 or less will be evaluated for the inclusion.

Being tested
Exenatide, Placebo
Keywords
Glucagon-Like Peptide 1, Positron-Emission Tomography
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExenatideDrug

    Injections, 2 mg once weekly for 18 months

  • PlaceboDrug

    Injections, once weekly for 18 months

Study groups in NCT04305002
Study groupRoleWhat they receive
ExenatideExperimentalNot described
Receives: Drug: Exenatide
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FDG-PET network analysis

    Measured: 21 months

Secondary outcomes (19)

  1. The sum score of MDS-UPDRS part 3 in ON and OFF-medication state

    Measured: 18 and 21 months

  2. MDS-UPDRS part 2

    Measured: 9, 18 and 21 months

  3. MDS-UPDRS part 4

    Measured: 9, 18 and 21 months

  4. Hoehn and Yahr

    Measured: 18 and 21 months

  5. Accelerometer (intensity of physical activity)

    Measured: 18 and 21 months

  6. Accelerometer (steps per day)

    Measured: 18 and 21 months

  7. Accelerometer (time of inactivity per day)

    Measured: 9, 18 and 21 months

  8. Levodopa equivalent daily dose (LEDD)

    Measured: Every 3 months

  9. PDQ-39 mobility subscore

    Measured: 18 months

  10. MDS-UPDRS part 1

    Non-motor symptom progression

    Measured: 18 and 21 months

  11. Non-Motor Symptoms Questionnaire (NMSQuest)

    Non-motor symptom progression

    Measured: 18 months

  12. PDQ-39 subscores (except for mobility)

    Non-motor symptom progression

    Measured: 18 months

  13. Epworth Sleepiness Scale (ESS)

    Non-motor symptom progression

    Measured: 18 months

  14. MADRS

    Non-motor symptom progression

    Measured: 6, 12 and 18 months

  15. Montreal Cognitive Assessment (MoCA)

    Non-motor symptom progression

    Measured: 21 months

  16. Brief Smell Identification Test (B-SIT)

    Non-motor symptom progression

    Measured: 18 months

  17. Frequency and severity of Adverse Events

    Measured: 21 months

  18. Exenatide-concentration csf

    Measured: Baseline, 9 and 21 months

  19. Exenatide levels in serum

    Measured: Baseline, 9, 18 and 21 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2020
  2. Study start21 Jan 2020
  3. Primary completion10 Oct 2023 (estimated)
  4. Study completion10 Oct 2023 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04305002
Sponsor's protocol ID
ExPD-ESR-18-13512
Status last verified
Sep 2022
First submitted
20 Feb 2020
Last updated
13 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Exenatide in people with Parkinson Disease, run by Center for Neurology, Stockholm at 1 site in Sweden.

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 8 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 13 Sep 2022. 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 Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

FDG-PET network analysis (time frame: 21 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04305002.

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 13 Sep 2022.

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