OLE Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001

Parkinson Disease Dementia Clinical Trial

Official title:

Open Label Extension Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04575259
• Other study ID #: ANAVEX2-73-PDD-EP-001
• Status: Completed
• Phase: Phase 2
• Start date: October 10, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: Anavex Life Sciences Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and efficacy of daily treatment.

Description:

This is a Phase 2 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and efficacy of daily treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: June 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Parkinson Disease
• Parkinson Disease Dementia

Intervention

Drug:
• ANAVEX2-73
Oral capsules

Locations

Country	Name	City	State
Australia	KaRa MINDS	Macquarie Park	New South Wales
Australia	Hammond Care	Malvern	Victoria
Spain	Hospital Mutua Terrasa	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital del Henares	Coslada
Spain	Clínica Universidad de Navarra (CUN) - Sede Madrid- Servicio de Neurología -	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario Puerta de Hierro	Madrid
Spain	Hospital Universitario Central de Asturias (HUCA)	Oviedo
Spain	Hospital Universitario Virgen del Rocío	Sevilla

Sponsors (3)

Lead Sponsor	Collaborator
Anavex Life Sciences Corp.	Anavex Australia Pty Ltd., Anavex Germany GmbH

Countries where clinical trial is conducted

Australia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Microbiota	Change from baseline to End of Treatment as measured by microbiota	48 weeks
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.03	To continue assessing the safety and tolerability of ANAVEX2-73	48 weeks
Secondary	RSBDQ (REM Sleep Behavior Disorder Screening Questionnaire)	Change from baseline to End of Treatment as measured by RSBDQ	48 weeks
Secondary	MDS-UPDRS Part III Total Score (Motor Scores)	Change from baseline to End of Treatment as measured by MDS-UPDRS Part III Total Score (Motor Scores)	48 weeks
Secondary	MoCA (Montreal Cognitive Assessment)	Change from baseline to End of Treatment as measured by MoCA	48 weeks