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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:  NCT03774459
Date of registration: 08/12/2018
Prospective Registration: Yes
Primary sponsor: Anavex Life Sciences Corp.
Public title: ANAVEX2-73 Study in Parkinson's Disease Dementia
Scientific title: 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
Date of first enrolment: July 9, 2018
Target sample size: 132
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03774459
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
Australia Spain
Contacts
Key inclusion & exclusion criteria

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.



Age minimum: 50 Years
Age maximum: 85 Years
Gender: All
Health Condition(s) or Problem(s) studied
Parkinsons Disease With Dementia
Intervention(s)
Drug: High dose ANAVEX2-73
Drug: Mid dose ANAVEX2-73
Drug: Placebo oral capsule
Primary Outcome(s)
Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention [Time Frame: 14 weeks]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time Frame: 14 weeks]
Secondary Outcome(s)
MDS-UPDRS Part III Total Score (Motor Scores) [Time Frame: 14 weeks]
SDS-CL-25 [Time Frame: 14 weeks]
Secondary ID(s)
ANAVEX2-73-PDD-001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Anavex Germany GmbH
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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