NCT03659682

Brief Summary

The purpose of the study is to test the neuroprotective and anti-inflammatory properties of semaglutide in idiopathic Parkinson's disease (PD)

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_2 parkinson-disease

Timeline
Completed

Started Jan 2019

Longer than P75 for phase_2 parkinson-disease

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 2, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

6 years

First QC Date

September 3, 2018

Last Update Submit

September 3, 2018

Conditions

Parkinson Disease

Keywords

GLP1R, neuroprotection, inflammation

Outcome Measures

Primary Outcomes (1)

  • Motor Function

    MDS-UPDRS part 3 in OFF medication state

    48 months

Study Arms (2)

semaglutide

ACTIVE COMPARATOR

Ozempic- 1.0 mg administered subcutaneously once weekly

Drug: Semaglutide

placebo

PLACEBO COMPARATOR

Placebo, 1.0 mg administered subcutaneously once weekly

Drug: Semaglutide

Interventions

SemaglutideDRUG

subcutaneous, 1.0 mg, weekly, 48 months

placebosemaglutide

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients will be excluded if they have chronic inflammatory brain disorders, as verified or diagnosed on brain magnetic resonance imaging (MRI). Cognitive impairment in PD will be excluded by way of Mini Mental Status (MMS, score \< 25 points) and Montreal Cognitive Assessment (MOCA, score \<25 points). The patients will be excluded if they have diabetes type 2 and cancer, especially if they or family members have familiar medullary thyroid carcinoma, or multiple endocrine neoplastic syndrome type 2 (MEN 2), as well as those having manifest kidney failure (see side effects below). The patients cannot receive long-term treatment with anti-inflammatory drugs, or other experimental drugs. Patients who are pregnant or breastfeeding are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson DiseaseInflammation

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Hanne F Harbo, MD, PhD

CONTACT

+47 230 72246h.f.harbo@medisin.uio.no

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: delayed start design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurologist

Study Record Dates

First Submitted

September 3, 2018

First Posted

September 6, 2018

Study Start

January 2, 2019

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

September 6, 2018

Record last verified: 2018-09