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

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

NCT04575259•Anavex Life Sciences Corp.

Summary

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

Detailed Description

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

Eligibility

Age

50 - 85 years

Sex

ALL

Healthy Volunteers

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).
+8 more criteria

Locations (10)

KaRa MINDS

Macquarie Park, New South Wales, Australia

Hammond Care

Malvern, Victoria, Australia

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

Seville, Spain

Key Dates

Start Date

October 10, 2019

Primary Completion Date

May 31, 2022

Completion Date

June 30, 2022

Last Updated

August 1, 2022

Enrollment

132

ACTUAL participants

Conditions

Parkinson Disease Dementia

Interventions

ANAVEX2-73

DRUG

Cholinergic Neurotransmission in Mobility and Cognition in Parkinson Disease

NCT03840837

Parkinson DiseaseParkinson Disease Dementia

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UNKNOWN

Dementias and Microbiota Composition: Is Possible to Revert the Dementia Symptoms Reverting the Microbiota Composition?

NCT05943925

Dementia AlzheimersDementia With Lewy Bodies+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Cholinergic Neurotransmission in Mobility and Cognition in Parkinson Disease

Dementias and Microbiota Composition: Is Possible to Revert the Dementia Symptoms Reverting the Microbiota Composition?

A Study to Evaluate Caregiver Connections Via Technology for Patients With Alzheimer's and Other Types of Dementia