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

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

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

Study Overview

• Status: Completed
• Conditions: Parkinson Disease Dementia
• Intervention / Treatment: Drug: ANAVEX2-73

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Macquarie Park, New South Wales, Australia
      • KaRa MINDS
  • Victoria
    • Malvern, Victoria, Australia
      • Hammond Care
• Spain
  • Barcelona, Spain
    • Hospital Universitario Vall d'Hebron
  • Barcelona, Spain
    • Hospital Mutua Terrasa
  • Coslada, Spain
    • Hospital del Henares
  • Madrid, Spain
    • Hospital Clinico San Carlos
  • Madrid, Spain
    • Hospital Universitario Puerta de Hierro
  • Madrid, Spain
    • Clínica Universidad de Navarra (CUN) - Sede Madrid- Servicio de Neurología -
  • Oviedo, Spain
    • Hospital Universitario Central de Asturias (HUCA)
  • Sevilla, Spain
    • Hospital Universitario Virgen del Rocio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ANAVEX2-73 Active; Oral capsules	Drug: ANAVEX2-73; Oral capsules; Other Names: Blarcamesine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03	To continue assessing the safety and tolerability of ANAVEX2-73	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RSBDQ (REM Sleep Behavior Disorder Screening Questionnaire)	Change from baseline to End of Treatment as measured by RSBDQ	48 weeks
MDS-UPDRS Part III Total Score (Motor Scores)	Change from baseline to End of Treatment as measured by MDS-UPDRS Part III Total Score (Motor Scores)	48 weeks
MoCA (Montreal Cognitive Assessment)	Change from baseline to End of Treatment as measured by MoCA	48 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiota	Change from baseline to End of Treatment as measured by microbiota	48 weeks

Collaborators and Investigators

• Sponsor: Anavex Life Sciences Corp.
• Collaborators: Anavex Australia Pty Ltd.; Anavex Germany GmbH

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Dementia
• Other Study ID Numbers: ANAVEX2-73-PDD-EP-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No