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Parkinson DiseasePhase 1NCT06309147

A Study to Assess the Safety of BMS-984923 Compared to Placebo, in People With Parkinson's

A Phase 1 study testing BMS-9894923 in people with Parkinson Disease, run by Allyx Therapeutics at 1 site in United States.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

A Phase 1, randomized, double-blind, placebo-controlled study of BMS-984923 administered orally twice daily (BID) for 28 days in participants with Parkinson's disease. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
BMS-9894923
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteUnited States
Study dates
15 Mar 2024to 15 Jul 2025
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 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women between the ages of 50 and 80 years, inclusive at the time of screening.
  • Clinical diagnosis of Parkinson's disease as defined by the United Kingdom Parkinson's disease (PD) Society Brain Bank Clinical Diagnostic Criteria and Movement Disorder Society Parkinson's disease Criteria (must meet both criteria); must include bradykinesia and responsiveness to levodopa.
  • Maintenance on stable Parkinson's disease therapy for at least 28 days prior to Screening/Visit 1 through treatment period to Day 42, with demonstratable medication efficacy as assessed by the Investigator.
  • Severity of Parkinson's disease symptoms assessed by Hoehn and Yahr Staging score ≤3.0 (assessed in the "ON" state).
  • Maintenance on permitted stable non-Parkinson's disease therapy for at least 28 days prior to Day 1 through the treatment period to Day 42.
  • Female participants of childbearing potential must have a negative urine pregnancy test at Screening and baseline, as well as be non-lactating and must agree to use a highly effective method of contraception during the study and for 30 days following last dose of study drug.
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  • Male participants must be sterile or sexually inactive or agree not to father a child during the study and for 1 month after the last dose of study medication and must agree to use a barrier method for contraception. Female partners of male subjects must adopt a highly effective method of contraception
  • Adequate visual, hearing, cognitive and physical ability and willingness to comply with study drug administration, scheduled visits, treatment plan, laboratory tests, and other study-related procedures to complete the study
  • Institutional Review Board/Ethics Committee-approved consent form signed and dated by the participant

Who cannot join

  • Diagnosis of secondary or atypical parkinsonism
  • Severe or disabling fluctuations or dyskinesias that would, in the opinion of the Investigator, interfere with completion of the study
  • Previous surgical procedure for Parkinson's disease (e.g. Duopa, deep brain stimulation)
  • Clinically significant cognitive impairment with a Montreal Cognitive Assessment score <18
  • Has a history or current evidence of long QT syndrome
  • Has bradycardia or tachycardia on the electrocardiogram (ECG) at Screening
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  • Clinical or laboratory findings consistent with another primary neurodegenerative disease or cognitive disorder other than Parkinson's disease, including but not limited to, frontotemporal lobar disease, Huntington's disease, progressive supranuclear palsy, multisystem atrophy, Jacob-Creutzfeld Disease, Down's syndrome, amyotrophic lateral sclerosis, seizure disorder, or other infectious, metabolic or systemic disease affecting the central nervous system including but not limited to, syphilis, present hypothyroidism, present vitamin B12 deficiency, or other laboratory abnormalities
  • Suicidality, defined as active suicidal thoughts or ideation or history of suicide attempt in previous 2 years, or, in the Investigator's opinion, at serious risk of suicide
  • Currently active major depression as determined by Beck Depression Inventory (BDI)-II score of >19
  • Has a history or current diagnosis of a psychiatric disorder such as schizophrenia, bipolar disorder or major depression according to the criteria of the most current version of the Diagnostic and Statistical Manual of Mental Disorders.
  • Clinically significant or unstable medical condition, including uncontrolled hypertension, or significant cardiac, pulmonary, hepatic, endocrine, or other systemic disease that in the Investigator's opinion may either put the participant at risk because of participation in the study, or influence the results, or impair the participant's ability to participate in the study
  • Any disorder that could interfere with absorption, distribution, metabolism or excretion of drugs (e.g., small bowel disease, Crohn's disease, celiac disease or liver disease)
  • Hospitalization or change of chronic concomitant medication within 8 weeks prior to baseline
  • Body mass index (BMI) >38 kg/m2 or body weight <50 kg
  • Has uncontrolled type 1 or type 2 diabetes. A subject with glycated hemoglobin (HbA1c) levels up to 7.5% can be enrolled if the Investigator believes the participant's diabetes is under control.
  • Has moderate or severe renal disease.
  • Has cancer or has had a malignant tumor (cerebral or systemic) within the past 3 years. (Participants with stable untreated prostate cancer or treated cutaneous squamous or basal cell carcinomas are not excluded)
  • Presence or history of psychosis, including if induced by anti-parkinsonian medications at doses required to improve motor symptoms, or hallucinations not induced by medications
  • Participant is currently pregnant, breast-feeding and/or lactating.
  • History of alcohol or substance abuse or dependence within the past 2 years.
  • Suspected or known allergy to any components of the study medication; Hypromellose Sodium lauryl sulfate, Lactose monohydrate, Croscarmellose sodium, Magnesium stearate.
  • Clinically significant abnormalities in B12 or thyroid function tests (TFTs) that might interfere with the study
  • Use of anticoagulants within 30 days or 5 half-lives (whichever is greater) prior to study drug administration and for the duration of the study
  • Use of another investigational agent within 90 days or 5 half-lives (whichever is greater) prior to Screening and for the duration of the study
  • Neutropenia defined as absolute neutrophil count of <1,500/microliter
  • Thrombocytopenia defined as platelet count <100,000/microliter
  • Clinically significant abnormalities in screening laboratory tests, including aspartate aminotransferase, alanine aminotransferase, total bilirubin, serum creatinine.
  • Male participants with female partners of child-bearing potential who are unwilling or unable to adhere to contraception requirements specified in the protocol.
  • Use of medications with potential drug-drug interactions within 2 weeks or 5 half-lives (whichever is greater) prior to study drug administration and for the duration of the study
  • Any contraindication to DaTscan, including claustrophobia, the presence of metal (ferromagnetic) implants, a cardiac pacemaker, or allergy to iodine
  • History of a seizure disorder, if stable on medication is acceptable
  • An immediate family member (i.e., spouse, parent, child, or sibling, whether biological or legally adopted) of the Investigator, Sponsor or contract research organizations conducting the trial
  • History of Covid-19 infection within 6 weeks prior to screening. Participants with unresolved symptoms of Covid-19 infection or ongoing cognitive or other deficits attributable to post-Covid-19, that may affect participant safety or interfere with cognitive assessments, based on the Investigator's clinical judgment.
  • Unable to comply with the protocol procedures or any significant issue raised by the Investigator that may compromise participant safety or potentially interfere with study interpretation.

Trial locations and contacts

1 site in 1 country.

Alexis Schuettke contact

919-668-2842

Alexis.schuettke@duke.edu

United States1 site, 1 recruiting

  • Duke Clinical Research Institute

    Durham, North Carolina, 27701

    Alexis Schuettke, 919-668-2842, alexis.schuettke@duke.edu

    Recruiting

Other trials in United States

About this study

Official title: A Double-Blind, Single Center, Randomized, Placebo-Controlled Study of BMS-984923 in Participants With Parkinson's Disease

A Phase 1, randomized, double-blind, placebo-controlled study of BMS-984923 administered orally twice daily (BID) for 28 days in participants with Parkinson's disease.

Read the detailed description

This double-blind placebo-controlled study will evaluate 28 days of twice daily dosing of BMS-984923 at two dose levels in comparison to placebo in participants with early Parkinson's disease.

This research study will assess the safety and tolerability of multiple doses of BMS-984923 for the treatment of early Parkinson's disease and investigate Dopamine transporter levels in the brain measured with single photon emission computed tomography as an early marker of therapeutic response to a treatment that targets synapse restoration.

Being tested
BMS-9894923
Keywords
Synapses, mGluR5 receptor, Silent allosteric modulator, Alzheimer's Disease
Medical subject headings
Parkinson Disease, Alzheimer Disease

What participants receive

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

  • BMS-9894923Drug

    Also called ALX-001

    50 mg capsules, oral administration

Study groups in NCT06309147
Study groupRoleWhat they receive
50 mg ActiveExperimental50mg BID
Receives: Drug: BMS-9894923
100mg ActiveExperimental100mg BID
Receives: Drug: BMS-9894923
Matching PlaceboPlacebo comparator50 and 100 mg matching placebo
Receives: Drug: BMS-9894923

What is being measured

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

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Safety

    Measured: Up to 14 days after last dose

Secondary outcomes (1)

  1. Area under the curve for the first 24 hours of dosing (AUC24h) and at steady state as determined by pharmacokinetic modeling

    Total plasma concentration as determined by pharmacokinetic modeling

    Measured: Up to 14 days after last dose

Timeline

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

  1. First posted13 Mar 2024
  2. Study start15 Mar 2024
  3. Primary completion15 Feb 2025 (estimated)
  4. Study completion15 Jul 2025 (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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double blind, parallel, 3-arm, placebo controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06309147
Sponsor's protocol ID
ALX-923-107
Status last verified
Mar 2024
First submitted
1 Mar 2024
Last updated
18 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ferreira DG, Temido-Ferreira M, Vicente Miranda H, Batalha VL, Coelho JE, Szego EM, Marques-Morgado I, Vaz SH, Rhee JS, Schmitz M, Zerr I, Lopes LV, Outeiro TF. alpha-synuclein interacts with PrPC to induce cognitive impairment through mGluR5 and NMDAR2B. Nat Neurosci. 2017 Nov;20(11):1569-1579. doi: 10.1038/nn.4648. Epub 2017 Sep 25.

    PubMed 28945221

  • Corbett GT, Wang Z, Hong W, Colom-Cadena M, Rose J, Liao M, Asfaw A, Hall TC, Ding L, DeSousa A, Frosch MP, Collinge J, Harris DA, Perkinton MS, Spires-Jones TL, Young-Pearse TL, Billinton A, Walsh DM. PrP is a central player in toxicity mediated by soluble aggregates of neurodegeneration-causing proteins. Acta Neuropathol. 2020 Mar;139(3):503-526. doi: 10.1007/s00401-019-02114-9. Epub 2019 Dec 18.

    PubMed 31853635

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMS-9894923 in people with Parkinson Disease, run by Allyx Therapeutics at 1 site 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 9 inclusion and 34 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 18 Mar 2024. 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alexis Schuettke (919-668-2842, Alexis.schuettke@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (TEAEs) (time frame: Up to 14 days after last dose). 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 NCT06309147, which also lists 2 linked publications.

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 18 Mar 2024.

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