ANAVEX2-73 Study in Parkinson's Disease Dementia

NCT03774459 | Completed Phase 2

• 1 other identifier: ANAVEX2-73-PDD-001
• Study Type: interventional
• Target: 132
• Locations: 2 countries
• Sites: 25

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)

Conditions

Parkinsons Disease With Dementia

Outcome Measures

Primary Outcomes (2)

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

  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

  14 weeks

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

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

  14 weeks

Secondary Outcomes (2)

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

  14 weeks

• SDS-CL-25

  14 weeks

Study Arms (3)

High dose ANAVEX2-73

EXPERIMENTAL

High dose ANAVEX2-73

Drug: High dose ANAVEX2-73

Mid dose ANAVEX2-73

EXPERIMENTAL

Mid dose ANAVEX2-73

Drug: Mid dose ANAVEX2-73

Placebo oral capsule

PLACEBO COMPARATOR

Placebo oral capsule

Drug: Placebo oral capsule

Interventions

High dose ANAVEX2-73 DRUG

Active oral capsule

High dose ANAVEX2-73

Mid dose ANAVEX2-73 DRUG

Active oral capsule

Mid dose ANAVEX2-73

Placebo oral capsule DRUG

Placebo oral capsule

Placebo oral capsule

Eligibility Criteria

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

You may qualify if:

• 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.

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 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.
• 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.

Sponsors & Collaborators

• Anavex Life Sciences Corp.: lead
• Anavex Germany GmbH: collaborator

Study Sites (25)

KaRa MINDS

Macquarie Park, Australia

Location

Hammond Health

Malvern, Australia

Location

Hospital Cruces Bilbao

Barakaldo, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Mutua Terrasa

Barcelona, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitario de Burgos

Burgos, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, Spain

Location

Hospital del Henares

Coslada, Spain

Location

Hospital General Universitario de Elche

Elche, Spain

Location

Hospital Arquitecto Marcide

Ferrol, Spain

Location

Hospital Santa Caterina

Girona, Spain

Location

Clinica Ruber Internacional

Madrid, Spain

Location

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

Madrid, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital de La Princesa

Madrid, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Infanta Leónor

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital HM Puerta del Sur

Móstoles, Spain

Location

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Spain

Location

Clínica Universidad de Navarra (CUN)

Pamplona, Spain

Location

Hospital de Santiago de Compostela

Santiago de Compostela, 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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2018
• First Posted: December 13, 2018
• Study Start: July 9, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

ES (23); AU (2)