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ANAVEX2-73 Study in Parkinson's Disease Dementia

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ClinicalTrials.gov Identifier: NCT03774459
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
Anavex Germany GmbH
Information provided by (Responsible Party):
Anavex Life Sciences Corp.

Tracking Information
First Submitted Date  ICMJE December 8, 2018
First Posted Date  ICMJE December 13, 2018
Last Update Posted Date December 13, 2018
Actual Study Start Date  ICMJE July 9, 2018
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention [ Time Frame: 14 weeks ]
    Change from Baseline to End of Treatment in Continuity of Attention as measured by Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention test
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 14 weeks ]
    Assess the safety and tolerability of ANAVEX2-73 compared to placebo
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • MDS-UPDRS Part III Total Score (Motor Scores) [ Time Frame: 14 weeks ]
    Change from baseline to End of Treatment as measured by MDS-UPDRS Part III Total Score (Motor Scores)
  • SDS-CL-25 [ Time Frame: 14 weeks ]
    Incidence of sleep disorders symptoms (SDS-CL-25)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ANAVEX2-73 Study in Parkinson's Disease Dementia
Official Title  ICMJE A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Patients With Parkinson's Disease With Dementia
Brief Summary A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Patients with Parkinson's Disease with Dementia (PDD)
Detailed Description This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, three-arm, 14-week study in PD patients with dementia. The study includes a 2 week Screening / Baseline Observation Period and a 14-week Treatment Period (including a 2 week Titration Period), and a 2-week Safety Follow-Up Period
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinsons Disease With Dementia
Intervention  ICMJE
  • Drug: High dose ANAVEX2-73
    Active oral capsule
  • Drug: Mid dose ANAVEX2-73
    Active oral capsule
  • Drug: Placebo oral capsule
    Placebo oral capsule
Study Arms  ICMJE
  • Experimental: High dose ANAVEX2-73
    High dose ANAVEX2-73
    Intervention: Drug: High dose ANAVEX2-73
  • Experimental: Mid dose ANAVEX2-73
    Mid dose ANAVEX2-73
    Intervention: Drug: Mid dose ANAVEX2-73
  • Placebo Comparator: Placebo oral capsule
    Placebo oral capsule
    Intervention: Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of idiopathic Parkinson's disease (PD) consistent with the UK Parkinson's Disease Society Brain Bank diagnostic criteria.
  • Diagnosis of probable PD dementia (PDD) according to the Movement Disorder Society Task Force clinical diagnostic criteria.
  • Montreal Cognitive Assessment (MoCA) score of 13 to 23, inclusive, at Screening.
  • Male or female and aged ≥ 50 years.
  • 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 randomization.
  • 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 like severe co-morbidities e.g. history of stroke, poor kidney or liver function 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

    1. abnormal thyroid function test at screening (TSH)
    2. abnormal B12 level at screening
    3. 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 randomization.
  • Use of over the counter (OTC) or prescription medication for sleep on 2 or more occasions per week (less than that is allowed).
  • 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 randomization.
  • Medications used for overactive bladder will be allowed provided that the regimen has been stable 4 weeks prior to randomization.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Director 844-689-3939 pdd@anavex.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03774459
Other Study ID Numbers  ICMJE ANAVEX2-73-PDD-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anavex Life Sciences Corp.
Study Sponsor  ICMJE Anavex Life Sciences Corp.
Collaborators  ICMJE Anavex Germany GmbH
Investigators  ICMJE Not Provided
PRS Account Anavex Life Sciences Corp.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP