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CompletedPhase 2

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

Asset

ANAVEX2-73

Listed sites

10

Recruiting sites

-

Enrollment

132

actual

Study population

Lewy body dementia

Key I/E criterion

•Parkinson's disease dementia

Primary endpoint

•Treatment-related adverse events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDANAVEX2-73-PDD-EP-001
NCT IDNCT04575259

Timeline

Milestones

Study start2019-10-10actual
Study first posted2020-10-05actual
Primary completion2022-05-31actual
Study completion2022-06-30actual
Last update posted2022-08-01actual

Assets

Drug assets

ANAVEX2-73

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

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).
•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.

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
2
Global cognition
1
Behavior / neuropsychiatric
1
Safety / tolerability / PK
1

Global cognition

1 endpoint
Secondary/protocol endpoint

MoCA (Montreal Cognitive Assessment)

Time frame:48 weeks

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

RSBDQ (REM Sleep Behavior Disorder Screening Questionnaire)

Time frame:48 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

Time frame:48 weeks

event count, event

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

MDS-UPDRS Part III Total Score (Motor Scores)

Time frame:48 weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Microbiota

Time frame:48 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.