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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04575259
Date of registration: 29/09/2020
Prospective Registration: No
Primary sponsor: Anavex Life Sciences Corp.
Public title: OLE Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001
Scientific title: Open Label Extension Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001
Date of first enrolment: October 10, 2019
Target sample size: 120
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04575259
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Australia Spain
Contacts
Key inclusion & exclusion 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.



Age minimum: 50 Years
Age maximum: 85 Years
Gender: All
Health Condition(s) or Problem(s) studied
Parkinson Disease Dementia
Intervention(s)
Drug: ANAVEX2-73
Primary Outcome(s)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [Time Frame: 48 weeks]
Secondary Outcome(s)
MDS-UPDRS Part III Total Score (Motor Scores) [Time Frame: 48 weeks]
MoCA (Montreal Cognitive Assessment) [Time Frame: 48 weeks]
RSBDQ (REM Sleep Behavior Disorder Screening Questionnaire) [Time Frame: 48 weeks]
Secondary ID(s)
ANAVEX2-73-PDD-EP-001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Anavex Australia Pty Ltd.
Anavex Germany GmbH
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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