Skip to main content
Delfa

← Trials/Trial dossier/NCT04184063

EMERA006

CompletedPhase 2

Study of NBMI Treatment in Patients With Atypical Parkinsons (PSP or MSA)

A Pilot Exploratory, Randomised, Placebo-controlled, Double Blinded, Cross-over , Phase 2a Study to Explore Efficacy and Safety of NBMI Treatment in Patients With Progressive Supranuclear Palsy (PSP) or Multiple System Atrophy (MSA)

Lead sponsor

EmeraMed

Asset

NBMI

Listed sites

1

Recruiting sites

-

Enrollment

20

actual

Study population

Frontotemporal dementia

Key I/E criteria

Age 40-85MRI contraindications excluded

Primary endpoints

Changes in Progressive Supranuclear Palsy rating Scale (PSPRS) individualMini-Mental State Examination (MMSE)Changes in Unified Multiple System Atrophy Rating Scale (UMSARS) individual

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDEMERA006
NCT IDNCT04184063

Timeline

Milestones

Study start2019-09-16actual
Study first posted2019-12-03actual
Primary completion2020-07-30actual
Study completion2021-06-30actual
Last update posted2021-09-23actual

Assets

Drug assets

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age40 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Patient has clinically confirmed documented diagnosis of PSP or MSA, according to the current clinical criteria.

2. Patient has a brain MRI finding consistent with the diagnosis of PSP or MSA at Screening.

3. Patient is aged 40 years to 85 years inclusive at screening age.

4. Patient is fluent in the local language and possesses sufficient auditory and visual capacities to allow neuropsychological testing.

5. Patient and caregiver are able to read and understand informed consent.

6. Patient is on a stable therapy for PSP, MSA for at least 1 month prior to screening visit.

7. If the patient received i.v. amantadine treatment, the last infusion must have been administered at least 6 months prior to the screening (V01).

8. Availability of a caregiver who sufficiently knows the patient and will be able to accompany the patient on the study visits and to participate in study assessments of the patient where required.

9. Female patients are only eligible for the study if they are either surgically sterile or at least 2 years postmenopausal or have a negative result of serum hCG test at screening and apply to criteria no. 10.

10. Female of childbearing potential can only participate in the study if willing to use acceptable, effective methods of contraception during the trial and for three month after the end of trial participation as defined in point 6.7. of this protocol.

11. Male patients must either be surgically sterile or he and his female spouse/partner who is of childbearing potential must be willing to use highly effective methods of contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continuing throughout the study.

12. Patient provides written informed consent

Exclusion criteria

1. Known history or presence of clinically significant other neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.

2. Known or suspected allergy hypersensitivity or idiosyncratic reaction to NBMI or any other drug substances with similar activity.

3. Patient has known contraindication for MRI imaging such as MRI-incompatible metallic endoprosthesis or MRI-incompatible stent implantation or other as judged by the Investigator.

4. Patient has claustrophobia that could prevent MRI imaging

5. History of drug or alcohol addiction requiring treatment.

6. Patient who had previous chronic exposure (within one year before recruitment) to iron from taking preparations/medications for rising iron

7. History of malabsorption within the last year or presence of clinically significant gastrointestinal disease or surgery that may affect drug bioavailability, including but not limited to cholecystectomy.

8. Patient is ridden to bed.

9. Presence of hepatic or renal dysfunction. (SGOT and SGPT and bilirubin > X2 UNL. creatinine > 1.5mg/dl)

10. Female patient who is pregnant (serum hCG level consistent with pregnancy diagnosis); or breastfeeding.

11. Participation in a clinical trial that involved administration of an investigational medicinal product within 90 days prior to drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results.

12. Patient has a history with evidence of cerebrovascular disease (ischemic or haemorrhagic), or diagnosis of possible, probable or definite vascular Parkinsonism or dementia.

13. Have clinically significant abnormal laboratory values (e.g. liver enzymes)

14. Have clinically significant findings from a physical examination (e.g. fever)

15. Patient has claustrophobia that could prevent him from attending MRI imaging

Endpoints (21)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
8
Behavior / neuropsychiatric
3
Other (unclassified)
3
Neuroimaging
2
Caregiver / quality of life
2
Global cognition
1
Memory
1
Function / daily living
1

Global cognition

1 endpoint
Primary/protocol endpoint

Changes in FAB individual scales scores from baseline in PSP patients compared to placebo treatment

Time frame:through study completion, an average of 85 days

Mini-Mental State Examination (MMSE)

descriptive

Memory

1 endpoint
Primary/protocol endpoint

Changes in Non-Motor Symptoms assessment scale (NMSS) individual scale from baseline in MSA patients compared to placebo treatment

Time frame:through study completion, an average of 85 days

event count, event

Function / daily living

1 endpoint
Primary/protocol endpoint

Changes in Unified Multiple System Atrophy Rating Scale (UMSARS) individual scale from baseline in MSA patients compared to placebo treatment

Time frame:through study completion, an average of 85 days

descriptive

Behavior / neuropsychiatric

3 endpoints
Primary/protocol endpoint

Changes in QOL individual scores from baseline by EQ-5D score in PSP patients compared to placebo treatment

Time frame:through study completion, an average of 85 days

descriptive

Secondary/protocol endpoint

Changes in Beck's Depression Inventory (BDI) scale (MSA patients) score from Baseline V1 to V2 (D29) and to V4 (D57) compared to placebo treatment

Time frame:through study completion, an average of 85 days

threshold achievement, improvement

Secondary/protocol endpoint

Changes in Geriatric depression scale (GDS) (PSP patients) score from Baseline - V1 to V2 (D29) and to V4 (D57) compared to placebo treatment

Time frame:through study completion, an average of 85 days

threshold achievement, improvement

Neuroimaging

2 endpoints
Other/protocol endpoint

Changes from baseline in brain metabolism as evaluated with Fluorodeoxyglucose Positron Emission Tomography (FDG PET) CT brain imaging compared to placebo treatment

Time frame:through study completion, an average of 85 days

descriptive

Other/protocol endpoint

Changes from baseline in brain iron levels as detected with Magnetic Resonance Imaging (MRI) imaging methods compared to placebo treatment

Time frame:through study completion, an average of 85 days

descriptive

Caregiver / quality of life

2 endpoints
Primary/protocol endpoint

Changes in QOL individual scores from baseline by MSA questionnaire in MSA patients

Time frame:through study completion, an average of 85 days

descriptive

Primary/protocol endpoint

Changes in QOL individual scores from baseline by MSA questionnaire in MSA patients using Visual Analog score

Time frame:through study completion, an average of 85 days

descriptive

Safety / tolerability / PK

8 endpoints
Secondary/protocol endpoint

Frequency, type and severity of adverse events compared to placebo treatment .

Time frame:through study completion, an average of 85 days

change from baseline, event

Other/protocol endpoint

Pharmacokinetic parameters derived from plasma concentrations of NBMI: Maximum Plasma Concentration [Cmax]

Time frame:Day 56, 57

concentration, descriptive

Other/protocol endpoint

Pharmacokinetic parameters derived from plasma concentrations of NBMI: AUC0-t

Time frame:Day 56, 57

concentration, descriptive

Other/protocol endpoint

Pharmacokinetic parameters derived from plasma concentrations of NBMI: AUC0-∞

Time frame:Day 56, 57

concentration, descriptive

Other/protocol endpoint

Pharmacokinetic parameters derived from plasma concentrations of NBMI: AUC%Extrap,obs

Time frame:Day 56, 57

concentration, descriptive

Other/protocol endpoint

Pharmacokinetic parameters derived from plasma concentrations of NBMI: t1/2

Time frame:Day 56, 57

concentration, descriptive

Other/protocol endpoint

Pharmacokinetic parameters derived from plasma concentrations of NBMI: λz

Time frame:Day 56, 57

concentration, descriptive

Other/protocol endpoint

Pharmacokinetic parameters derived from plasma concentrations of NBMI: T max

Time frame:Day 56, 57

concentration, descriptive

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

Changes in Progressive Supranuclear Palsy rating Scale (PSPRS) individual scales scores from baseline in PSP patients compared to placebo treatment

Time frame:through study completion, an average of 85 days

descriptive

Secondary/protocol endpoint/low confidence

Changes in Parkinson's Disease Fatigue Score (PFS) score from Baseline - V1 to V2 (D29) and V1 to V5 (D57) in PSP and MSA patients compared to placebo treatment

Time frame:through study completion, an average of 85 days

event count, event

Secondary/protocol endpoint/low confidence

Percentage of NBMI-treated patients who develop a response to NBMI.

Time frame:through study completion, an average of 85 days

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.