AzTrials
AzTrials

Parkinson Disease DementiaPhase 2NCT04575259

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

A Phase 2 study testing ANAVEX2-73 in people with Parkinson Disease Dementia, run by Anavex Life Sciences Corp. at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Parkinson Disease Dementia
What is being tested?
ANAVEX2-73
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
10 sitesin 2 countries
Study dates
10 Oct 2019to 30 Jun 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

Spain8 sites

  • Hospital Mutua Terrasa

    Barcelona

  • Hospital Universitario Vall d'Hebron

    Barcelona

  • Hospital del Henares

    Coslada

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

    Madrid

  • Hospital Clínico San Carlos

    Madrid

  • Hospital Universitario Puerta de Hierro

    Madrid

  • Hospital Universitario Central de Asturias (HUCA)

    Oviedo

  • Hospital Universitario Virgen del Rocío

    Seville

Other trials in Spain

Australia2 sites

  • KaRa MINDS

    Macquarie Park, New South Wales

  • Hammond Care

    Malvern, Victoria

Other trials in Australia

About this study

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

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

Read the 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.

Being tested
ANAVEX2-73

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ANAVEX2-73Drug

    Also called Blarcamesine

    Oral capsules

Study groups in NCT04575259
Study groupRoleWhat they receive
ANAVEX2-73 ActiveExperimentalOral capsules
Receives: Drug: ANAVEX2-73

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 48 weeks

Secondary outcomes (3)

  1. RSBDQ (REM Sleep Behavior Disorder Screening Questionnaire)

    Change from baseline to End of Treatment as measured by RSBDQ

    Measured: 48 weeks

  2. 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)

    Measured: 48 weeks

  3. MoCA (Montreal Cognitive Assessment)

    Change from baseline to End of Treatment as measured by MoCA

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2020
  2. Study start10 Oct 2019
  3. Primary completion31 May 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04575259
Sponsor's protocol ID
ANAVEX2-73-PDD-EP-001
Status last verified
Jul 2022
First submitted
29 Sep 2020
Last updated
1 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ANAVEX2-73 in people with Parkinson Disease Dementia, run by Anavex Life Sciences Corp. at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Spain, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04575259.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in