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

NCT04575259 | Completed Phase 2

• 1 other identifier: ANAVEX2-73-PDD-EP-001
• Study Type: interventional
• Target: 132
• Locations: 2 countries
• Sites: 10

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.

Conditions

Parkinson Disease Dementia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• RSBDQ (REM Sleep Behavior Disorder Screening Questionnaire)

  48 weeks

• MDS-UPDRS Part III Total Score (Motor Scores)

  48 weeks

• MoCA (Montreal Cognitive Assessment)

  48 weeks

Other Outcomes (1)

• Microbiota

  48 weeks

Study Arms (1)

ANAVEX2-73 Active

EXPERIMENTAL

Oral capsules

Drug: ANAVEX2-73

Interventions

ANAVEX2-73 DRUG

Oral capsules

Also known as: Blarcamesine

ANAVEX2-73 Active

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anavex Life Sciences Corp.: lead
• Anavex Australia Pty Ltd.: collaborator
• Anavex Germany GmbH: collaborator

Study Sites (10)

KaRa MINDS

Macquarie Park, New South Wales, Australia

Location

Hammond Care

Malvern, Victoria, Australia

Location

Hospital Mutua Terrasa

Barcelona, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Location

Hospital del Henares

Coslada, Spain

Location

Clínica Universidad de Navarra (CUN) - Sede Madrid- Servicio de Neurología -

Madrid, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, Spain

Location

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

MeSH Terms

Interventions

tetrahydro-N, N-dimethyl-2,2-diphenyl-3-furanmethanamine hydrochloride

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 5, 2020
• Study Start: October 10, 2019
• Primary Completion: May 31, 2022
• Study Completion: June 30, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

AU (2); ES (8)