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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03774459




Registration number
NCT03774459
Ethics application status
Date submitted
8/12/2018
Date registered
13/12/2018
Date last updated
22/10/2020

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

Health condition
Health condition(s) or problem(s) studied:
Parkinsons Disease With 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 - High dose ANAVEX2-73
Treatment: Drugs - Mid dose ANAVEX2-73
Treatment: Drugs - Placebo oral capsule

Experimental: High dose ANAVEX2-73 - High dose ANAVEX2-73

Experimental: Mid dose ANAVEX2-73 - Mid dose ANAVEX2-73

Placebo Comparator: Placebo oral capsule - Placebo oral capsule


Treatment: Drugs: High dose ANAVEX2-73
Active oral capsule

Treatment: Drugs: Mid dose ANAVEX2-73
Active oral capsule

Treatment: Drugs: Placebo oral capsule
Placebo oral capsule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention
Timepoint [1] 0 0
14 weeks
Primary outcome [2] 0 0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Timepoint [2] 0 0
14 weeks
Secondary outcome [1] 0 0
MDS-UPDRS Part III Total Score (Motor Scores)
Timepoint [1] 0 0
14 weeks
Secondary outcome [2] 0 0
SDS-CL-25
Timepoint [2] 0 0
14 weeks

Eligibility
Key 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.
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 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
9/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2020
Sample size
Target
Accrual to date
Final
132
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
KaRa MINDS - Macquarie Park
Recruitment hospital [2] 0 0
Hammond Health - 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
Barakaldo
Country [2] 0 0
Spain
State/province [2] 0 0
Barcelona
Country [3] 0 0
Spain
State/province [3] 0 0
Burgos
Country [4] 0 0
Spain
State/province [4] 0 0
Cadiz
Country [5] 0 0
Spain
State/province [5] 0 0
Coslada
Country [6] 0 0
Spain
State/province [6] 0 0
Elche
Country [7] 0 0
Spain
State/province [7] 0 0
Ferrol
Country [8] 0 0
Spain
State/province [8] 0 0
Girona
Country [9] 0 0
Spain
State/province [9] 0 0
Madrid
Country [10] 0 0
Spain
State/province [10] 0 0
Móstoles
Country [11] 0 0
Spain
State/province [11] 0 0
Oviedo
Country [12] 0 0
Spain
State/province [12] 0 0
Pamplona
Country [13] 0 0
Spain
State/province [13] 0 0
Santiago de Compostela
Country [14] 0 0
Spain
State/province [14] 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 Germany GmbH
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/ct2/show/NCT03774459
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/NCT03774459