An Early Phase 1 interventional study of [11C]MODAG-005 in Parkinson Disease (PD), MSA - Multiple System Atrophy and Healthy Adult Participants, sponsored by MODAG GmbH. Recruiting at 1 site in Germany. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by MODAG GmbH · Early Phase 1, Interventional, and Diagnostic
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Among 263 studies in Parkinson Disease with a site in Germany — 41 open to participants now, 53 under way, 2 of them phase 3. Parkinson Disease · Germany.
Among the 263 studies in Parkinson Disease with a site in Germany, this one is the 190th largest by planned enrollment of the 198 interventional ones that give a count, is one of 8 that started in 2026, is one of 13 in phase 1, reaches primary completion later than 25 of the 52 other live ones, and was the 263rd registered.
4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.
Browse Parkinson Disease studies →41 of the 263 studies in Parkinson Disease with a site in Germany are open now. Recruiting first, the newest first:
University Hospital Tuebingen · Sites in Germany, France, Italy and 4 more countries
Ages 35–80
H. Lundbeck A/S · Sites in Germany, United States, Czechia and 1 more country
Ages 40–85
University Hospital Muenster · Sites in Germany
Ages 18+
Integrative Research Laboratories AB · Sites in Germany, Bulgaria, Poland and 1 more country
Ages 50–90
University Hospital, Bonn · Sites in Germany
Ages 50–80 · Healthy volunteers
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 750 Parkinson Disease studies recruiting now, 312 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 190 take healthy volunteers.
This study: 50 Years to 75 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
263 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 16 · Phase 2 53 · Phase 3 65 · Phase 4 19
First in 2001; this study’s year is marked. 8 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 9 is below the median of 40 across 3,355 interventional studies indexed under Parkinson Disease.
Median enrollment 106 across the 198 interventional studies, 194 across the 63 observational. Of the 185 that completed or were terminated, 73 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
172 of 263 have an industry lead sponsor. The 10 most frequent:
MODAG GmbH is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
MODAG GmbH has 6 studies filed under Parkinson Disease — fewer than ten, so there is no comparison to draw.
15 of the studies in Parkinson Disease with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07134634Parkinson's Clinic in Beelitz-HeilstattenEffect of a Vibrating Therapy Ball on Tremor and Daily Activities in Patients With Different Tremor Syndroms | 2026-11 |
| NCT06580977Heidelberg UniversityExploring the Effects of Exercise on Memory and Cognition in Parkinson´s Disease | 2026-12 |
| NCT07141719University of KielCollection of Digital Parameters From Parts of the Neurological Examination Using an Eye Tracker | 2026-12-31 |
| NCT06602193Denali Therapeutics Inc.Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD) | 2027-03 |
| NCT06993571Universitätsklinikum Hamburg-EppendorfCerebellar Transcranial Alternating Current Stimulation (tACS) to Modulate Parkinson's Disease Tremor | 2027-03-31 |
Add all 15 to your calendar (.ics) → With an account.
Among the 263 studies in Parkinson Disease with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is an open-label, single-center Phase 1 study evaluating the safety, tolerability, and test-retest characteristics of [11C]MODAG-005, an investigational positron emission tomography/computed tomography (PET/CT) radioligand intended to image pathological alpha-synuclein deposition in the brain. The study will enroll participants with Parkinson's disease (PD), participants with multiple system atrophy (MSA), and age-matched healthy controls (AMHC).
Participants with PD or MSA will undergo two [11C]MODAG-005 PET/CT imaging sessions: one baseline scan and one follow-up scan 7 to 48 days later. Age-matched healthy controls will undergo one baseline scan. A subset of PD and MSA participants will receive a single oral dose of anle138b (Emrusolmin) before the second scan to evaluate tracer uptake under blocking conditions. The primary objective is to assess the safety and tolerability of [11C]MODAG-005. Secondary objectives include evaluating whether [11C]MODAG-005 PET imaging can distinguish participants with MSA or PD from age-matched healthy controls, distinguish PD from MSA, and determine test-retest variability of PET outcome measures.
This is an open-label, single-center Phase 1 study evaluating [11C]MODAG-005, an investigational Positron Emission Tomography (PET) radioligand for imaging pathological alpha-synuclein deposition in the brain. The study will enroll participants with Parkinson's disease (PD), participants with multiple system atrophy (MSA), and age-matched healthy controls (AMHC).
Participants with PD or MSA will undergo two [11C]MODAG-005 PET/CT scans: a baseline scan and a follow-up scan 7 to 48 days later. Age-matched healthy controls will undergo one baseline PET/CT scan. A subset of PD and MSA participants will receive a single oral dose of 300 mg anle138b (Emrusolmin) before the second scan to evaluate tracer uptake under blocking conditions.
The primary objective is to assess the safety and tolerability of [11C]MODAG-005 based on adverse events, vital signs, physical examinations, laboratory tests, and electrocardiograms. Secondary objectives include evaluating whether [11C]MODAG-005 PET imaging can distinguish MSA from healthy controls, PD from healthy controls, and PD from MSA, and assessing test-retest variability of PET imaging measures.
Exploratory analyses will assess tracer uptake with and without anle138b blocking, blood radioactivity and metabolite profiles, image-derived input functions, visual PET reads, and relationships between PET signal and clinical measures. Total study participation will last up to 12 weeks from screening to final follow-up.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Unwilling and/or unable to cooperate with trial procedures.
Exclusion criteria for age-matched healthy controls:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each participant with PD and each participant with MSA will receive two injections of up to 18 mL of \[11C\]MODAG-005 solution for injection with 40 - 400 MBq within 12 weeks. Each HC will receive one injection of up to 18 mL of \[11C\]MODAG-005 solution for injection with 40 - 400 MBq.
Drug: [11C]MODAG-005
Injection of \[11C\]MODAG-005 followed by PET imaging.
Safety and Tolerability
AEs related to the medication
Time frame: Inclusion to 4 days (± 2 days) post injection.
Safety and tolerability
AEs leading to discontinuation/drop-out rates
Time frame: Inclusion to 4 days (± 2 days) post injection.
Safety and tolerability
SAEs related to the study medication.
Time frame: Inclusion to 4 days (± 2 days) post injection.
Safety and tolerability
Change in vital signs (heart rate \[Hz\], blood pressure \[mmHg\], body temperature\[°C\]) secondary to injection with \[11C\]MODAG-005.
Time frame: Inclusion to 4 days (± 2 days) post injection.
Safety and tolerability
Change in physical examination findings secondary to injection with \[11C\]MODAG-005.
Time frame: Inclusion to 4 days (± 2 days) post injection.
Safety and tolerability
Change in clinical laboratory results including hematology and clinical chemistry including renal function tests, hepatic enzymes, electrolytes and creatine kinase secondary to injection with \[11C\]MODAG-005.
Time frame: Inclusion to 4 days (± 2 days) post injection.
Safety and tolerability
Cahnge in 12-lead ECG parameters including QT interval corrected for heart rate using Fridericia's formula (QTcF) secondary to injection with \[11C\]MODAG-005
Time frame: Inclusion to 4 days (± 2 days) post injection.
To assess the ability of [11C]MODAG-005 to discriminate between MSA and HC.
Standardized uptake value ratio (SUVR) for different imaging time windows, volume of distribution (VT) and distribution volume ratio (DVR) in different brain regions between participants with MSA and AMHC from PET acquisitions after administration of \[11C\]MODAG-005.
Time frame: Slots between 0 and 90 minutes after tracer injection.
To assess the ability of [11C]MODAG-005 to discriminate between PD and HC
SUVR for different imaging time windows, VT, and DVRin different brain regions between patients with PD and AMHC from PET acquisitions after administration of \[11C\]MODAG-005.
Time frame: Slots between 0 and 90 minutes after tracer injection.
To assess the ability of [11C]MODAG-005 to discriminate between PD and MSA
SUVR for different imaging time windows, VT, and DVR in different brain regions between participants with PD and participants with MSA from PET acquisitions after administration of \[11C\]MODAG-005.
Time frame: Slots between 0 and 90 minutes after tracer injection.
To determine test-retest variability in PD and MSA under blocking conditions.
Test-retest variability of SUVR for different time imaging time windows and DVR after administration of \[11C\]MODAG-005 in PD and MSA under blocking with a single dose of Emrusolmin 300 mg.
Time frame: 8-49 days after first tracer injection.
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jul 2027, 12 months after the start.
Of 127 industry-sponsored phase 1 interventional studies under Parkinson Disease, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 24. This study's planned 12 months is above that.
Counting every sponsor, half of 204 studies reached it within 19 months; a quarter within 5 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
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