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

Anavex Life Sciences Corp.25 sites in 2 countries132 target enrollmentJuly 9, 2018

ConditionsParkinsons Disease With Dementia

InterventionsHigh dose ANAVEX2-73 Mid dose ANAVEX2-73 Placebo oral capsule

DrugsHigh dose ANAVEX2-73 Mid dose ANAVEX2-73 Placebo oral capsule

Overview

Phase: Phase 2
Intervention: High dose ANAVEX2-73
Conditions: Parkinsons Disease With Dementia
Sponsor: Anavex Life Sciences Corp.
Enrollment: 132
Locations: 25
Primary Endpoint: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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)

Detailed Description

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, three-arm, 14-week study in PD patients with dementia. The study includes a 2 week Screening / Baseline Observation Period and a 14-week Treatment Period (including a 2 week Titration Period), and a 2-week Safety Follow-Up Period

Registry

clinicaltrials.gov

Start Date

July 9, 2018

End Date

September 30, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Anavex Life Sciences Corp.

Responsible Party

Sponsor

Eligibility Criteria

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:

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
•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 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.

Arms & Interventions

High dose ANAVEX2-73

Intervention: High dose ANAVEX2-73

Mid dose ANAVEX2-73

Intervention: Mid dose ANAVEX2-73

Placebo oral capsule

Intervention: Placebo oral capsule

Outcomes

Primary Outcomes

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame: 14 weeks

Assess the safety and tolerability of ANAVEX2-73 compared to placebo

Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention

Time Frame: 14 weeks

Change from Baseline to End of Treatment in Continuity of Attention as measured by Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention test