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OLE Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04575259
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : October 6, 2020
Sponsor:
Collaborators:
Anavex Australia Pty Ltd.
Anavex Germany GmbH
Information provided by (Responsible Party):
Anavex Life Sciences Corp.

Brief Summary:
This is a Phase 2 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and efficacy of daily treatment.

Condition or disease Intervention/treatment Phase
Parkinson Disease Dementia Drug: ANAVEX2-73 Phase 2

Detailed Description:
This is a Phase 2 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and efficacy of daily treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Extension Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001
Actual Study Start Date : October 10, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ANAVEX2-73 Active
Oral capsules
Drug: ANAVEX2-73
Oral capsules
Other Name: Blarcamesine




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 48 weeks ]
    To continue assessing the safety and tolerability of ANAVEX2-73


Secondary Outcome Measures :
  1. RSBDQ (REM Sleep Behavior Disorder Screening Questionnaire) [ Time Frame: 48 weeks ]
    Change from baseline to End of Treatment as measured by RSBDQ

  2. MDS-UPDRS Part III Total Score (Motor Scores) [ Time Frame: 48 weeks ]
    Change from baseline to End of Treatment as measured by MDS-UPDRS Part III Total Score (Motor Scores)

  3. MoCA (Montreal Cognitive Assessment) [ Time Frame: 48 weeks ]
    Change from baseline to End of Treatment as measured by MoCA


Other Outcome Measures:
  1. Microbiota [ Time Frame: 48 weeks ]
    Change from baseline to End of Treatment as measured by microbiota



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous completion of participation in the ANAVEX2-73-PDD-001 study.
  • Caregivers and subjects (or legal representative) must understand and have signed approved informed consent.
  • Caregivers and subjects (or legal representative) must be able to understand study requirements and be willing to follow instructions.
  • Stable regimen of anti-Parkinson's disease medications (including levodopa, dopamine agonists, MAO-B inhibitors, or the COMT inhibitor entacapone), which has been stable for at least 4 weeks prior to Baseline.
  • Treatment with cholinesterase inhibitor (rivastigmine, donepezil and galantamine (Exelon®, Aricept®, or Reminyl®) will be permitted, provided the dose has been stable for a minimum of 8 weeks prior to joining this study.
  • Subjects with history of depression on antidepressant medications will be allowed if depression is controlled and they have been on a stable daily dose of the antidepressant for ≥8 weeks before Baseline.
  • Contraception: Women of childbearing potential must use an acceptable method of contraception starting 4 weeks prior to study drug administration and for a minimum of 4 weeks after study completion. Otherwise, women must be postmenopausal (at least one year absence of vaginal bleeding or spotting) as confirmed by FSH greater than or equal to 40 mIU/mL or 40 IU/L or be surgically sterile.
  • Men with a potentially fertile partner must have had a vasectomy or be willing to use an acceptable method of contraception for the duration of the study and for 3 months after study drug discontinuation.

Exclusion Criteria:

  • History of any significant neurologic or psychiatric disorder other than PD that can contribute to cognitive impairment.
  • Any other condition or clinically significant abnormal findings on the physical or neurological examination, medical and psychiatric history, at screening or at baseline that, in the opinion of the Investigator, would make the subject unsuitable for the study.
  • Potential symptomatic causes of cognitive impairment including but not limited to
  • abnormal thyroid function test at screening (TSH)
  • abnormal B12 level at screening
  • MRI findings (by history) pointing to a potential symptomatic cause of cognitive dysfunction, including significant vascular changes, or communicating hydrocephalus.
  • Treatment with memantine or amantadine. If appropriate the drugs can be discontinued for a minimum of 4 weeks prior to enrollment.
  • History of depression as measured by Beck Depression Inventory score >17 at screening.
  • Treatment with any other investigational drug or device within 4 weeks prior to screening.
  • Smoking > 1 pack of cigarettes per day (as assessed for the 4 weeks prior to screening).
  • Women who are pregnant or lactating.
  • Known allergy or sensitivity to ANAVEX2-73 or any of its components.
  • Suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS) of type 4 or type 5, or any suicidal behavior, in the past 6 months. Type 4 indicates active suicidal ideation with some intent to act, without a specific plan. Type 5 indicates active suicidal ideation with a specific plan and intent.
  • Use of centrally acting anticholinergic drugs during the 4 weeks before enrollment.
  • Medications used for overactive bladder will be allowed provided that the regimen has been stable 4 weeks prior to enrollment.
  • Treatment with any dopamine receptor blocking medications with the exception of low dose quetiapine (≤50 mg/day). Pimavanserin (≤34 mg/day) will be allowed.
  • History of neurosurgical intervention (e.g., deep brain stimulation) for PD.
  • Unpredictable motor fluctuations that would interfere with administering cognitive assessments in the ON state.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04575259


Locations
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Australia, New South Wales
KaRa MINDS Recruiting
Macquarie Park, New South Wales, Australia
Contact: Rosalyn Lai, Dr    +61 2 8960 7788    info@karaminds.com   
Australia, Victoria
Hammond Care Recruiting
Malvern, Victoria, Australia
Contact: Stephen Macfarlane, A/Prof    +61 1300 426 666    info@dementiacentre.com   
Spain
Hospital Mutua Terrasa Recruiting
Barcelona, Spain
Contact: Pau Pastor    +34 937 36 70 20    contacta@mutuaterrassa.com   
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain
Contact: Jorge Hernández Vara    +34 934 89 30 00    contacta@vallhebron.com   
Hospital del Henares Recruiting
Coslada, Spain
Contact: Elena Toribio    +34 911 91 20 00    contacta@comunidad.com   
Clínica Universidad de Navarra (CUN) - Sede Madrid- Servicio de Neurología - Recruiting
Madrid, Spain
Contact: Antonio Martín Bastida    +34 913 53 19 20    madridcunatpacte@unav.es   
Hospital Clínico San Carlos Recruiting
Madrid, Spain
Contact: Rocío García Ramos    +34 913 30 30 00    neurol.hcsc@salud.madrid.org   
Hospital Universitario Puerta de Hierro Recruiting
Madrid, Spain
Contact: Pilar Sánchez    +34 911 91 60 00    atepac.hpth@salud.madrid.org   
Hospital Universitario Central de Asturias (HUCA) Recruiting
Oviedo, Spain
Contact: Marta Blázquez Estrada    +34 985 10 80 00    contacta@hca.es   
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, Spain
Contact: Pablo Mir    +34 955 01 20 00    uec.hvr.sspa@juntadeandalucia.es   
Sponsors and Collaborators
Anavex Life Sciences Corp.
Anavex Australia Pty Ltd.
Anavex Germany GmbH
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Responsible Party: Anavex Life Sciences Corp.
ClinicalTrials.gov Identifier: NCT04575259    
Other Study ID Numbers: ANAVEX2-73-PDD-EP-001
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Dementia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders