Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04575259




Registration number
NCT04575259
Ethics application status
Date submitted
29/09/2020
Date registered
5/10/2020
Date last updated
1/08/2022

Titles & IDs
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
Secondary ID [1] 0 0
ANAVEX2-73-PDD-EP-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson Disease Dementia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ANAVEX2-73

Experimental: ANAVEX2-73 Active - Oral capsules


Treatment: Drugs: ANAVEX2-73
Oral capsules
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Timepoint [1] 0 0
48 weeks
Secondary outcome [1] 0 0
RSBDQ (REM Sleep Behavior Disorder Screening Questionnaire)
Timepoint [1] 0 0
48 weeks
Secondary outcome [2] 0 0
MDS-UPDRS Part III Total Score (Motor Scores)
Timepoint [2] 0 0
48 weeks
Secondary outcome [3] 0 0
MoCA (Montreal Cognitive Assessment)
Timepoint [3] 0 0
48 weeks

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2022
Sample size
Target
Accrual to date
Final
132
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
KaRa MINDS - Macquarie Park
Recruitment hospital [2] 0 0
Hammond Care - Malvern
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment postcode(s) [2] 0 0
- Malvern
Recruitment outside Australia
Country [1] 0 0
Spain
State/province [1] 0 0
Barcelona
Country [2] 0 0
Spain
State/province [2] 0 0
Coslada
Country [3] 0 0
Spain
State/province [3] 0 0
Madrid
Country [4] 0 0
Spain
State/province [4] 0 0
Oviedo
Country [5] 0 0
Spain
State/province [5] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Anavex Life Sciences Corp.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Anavex Australia Pty Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Anavex Germany GmbH
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04575259
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04575259