Parkinsons Disease With DementiaPhase 2NCT03774459
ANAVEX2-73 Study in Parkinson's Disease Dementia
A Phase 2 study testing High dose ANAVEX2-73 and Mid dose ANAVEX2-73 in people with Parkinsons Disease With Dementia, run by Anavex Life Sciences Corp. at 25 sites in 2 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinsons Disease With Dementia
- What is being tested?
- High dose ANAVEX2-73 and Mid dose ANAVEX2-73
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 9 Jul 2018to 30 Sep 2020
- 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
- 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.
Show all 12Show fewer
- 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.
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 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.
Show all 19Show fewer
- 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.
- Medications used for overactive bladder will be allowed provided that the regimen has been stable 4 weeks prior to randomization.
- 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
25 sites in 2 countries.
25 sites in 2 countries
Spain23 sites
Hospital Cruces Bilbao
Barakaldo
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Mutua Terrasa
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Hospital Universitario de Burgos
Burgos
Hospital Universitario Puerta del Mar
Cadiz
Hospital del Henares
Coslada
Hospital General Universitario de Elche
Elche
Hospital Arquitecto Marcide
Ferrol
Hospital Santa Caterina
Girona
Clinica Ruber Internacional
Madrid
Clínica Universidad de Navarra (CUN) - Sede Madrid- Servicio de Neurología -
Madrid
Hospital Clínico San Carlos
Madrid
Hospital de La Princesa
Madrid
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Infanta Leónor
Madrid
Hospital Universitario Puerta de Hierro
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital HM Puerta del Sur
Móstoles
Hospital Universitario Central de Asturias (HUCA)
Oviedo
Clínica Universidad de Navarra (CUN)
Pamplona
Hospital de Santiago de Compostela
Santiago de Compostela
Hospital Universitario Virgen del Rocío
Seville
About this study
Official title: 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
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)
Read the 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
- Conditions
- Parkinsons Disease With Dementia
- Being tested
- High dose ANAVEX2-73, Mid dose ANAVEX2-73, Placebo oral capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose ANAVEX2-73Drug
Active oral capsule
Mid dose ANAVEX2-73Drug
Active oral capsule
Placebo oral capsuleDrug
Placebo oral capsule
| Study group | Role | What they receive |
|---|---|---|
| High dose ANAVEX2-73 | Experimental | High dose ANAVEX2-73 Receives: Drug: High dose ANAVEX2-73 |
| Mid dose ANAVEX2-73 | Experimental | Mid dose ANAVEX2-73 Receives: Drug: Mid dose ANAVEX2-73 |
| Placebo oral capsule | Placebo comparator | Placebo oral capsule Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 14 weeks
Secondary outcomes (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: 14 weeks
SDS-CL-25
Incidence of sleep disorders symptoms (SDS-CL-25)
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start9 Jul 2018
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsons Disease With DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anavex Life Sciences Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Anavex Germany GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774459
- Sponsor's protocol ID
- ANAVEX2-73-PDD-001
- Status last verified
- Oct 2020
- First submitted
- 8 Dec 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03774459
- Acronym / sponsor ID
- ANAVEX2-73-PDD-001
- Conditions
- Parkinsons Disease With Dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Anavex Life Sciences Corp.Industry (pharma, biotech, devices)
- Collaborators
- Anavex Germany GmbH
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 13 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose ANAVEX2-73 | Experimental | Drug: High dose ANAVEX2-73High dose ANAVEX2-73 |
| Mid dose ANAVEX2-73 | Experimental | Drug: Mid dose ANAVEX2-73Mid dose ANAVEX2-73 |
| Placebo oral capsule | Placebo comparator | Drug: Placebo oral capsulePlacebo oral capsule |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dose ANAVEX2-73Active oral capsule | Drug | High dose ANAVEX2-73 |
| Mid dose ANAVEX2-73Active oral capsule | Drug | Mid dose ANAVEX2-73 |
| Placebo oral capsulePlacebo oral capsule | Drug | Placebo oral capsule |
Primary outcome
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
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
2 secondary outcomes
MDS-UPDRS Part III Total Score (Motor Scores)
Time frame: 14 weeks
SDS-CL-25
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
Related trials for Parkinsons Disease With Dementia
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Recruiting
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
Amnesia, Alzheimer Disease
RecruitingEarly Phase 1
[18F]ACI-15916 PET in α-synucleinopathies
Parkinson's Disease (PD), Multiple System Atrophy (MSA)
RecruitingObservational study
Parkinson's Disease and Movement Disorders Clinical Database
Parkinson Disease, Parkinson Disease Dementia
Not yet recruiting
Adaptango Performance PRocess for Older Adults Community reHabilitation
Parkinson Disease, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High dose ANAVEX2-73 and Mid dose ANAVEX2-73 in people with Parkinsons Disease With Dementia, run by Anavex Life Sciences Corp. at 25 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 12 inclusion and 19 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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. Some participants in this study may receive a placebo. 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?
Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention (time frame: 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2020.