Anavex Life Sciences Corp (AVXL)

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WHY WOULD AVXL ALLOW DPZ USE DURING THE A2-73 P2 PDD TRIAL IF IT HAD A SIGNIFICANT EFFECT ON PATIENT RESPONSE TO A2-73??????????????????????


https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-004335-36/ES

E.3 Principal inclusion criteria
1. Diagnosis of idiopathic Parkinson’s disease (PD) consistent with the UK Parkinson’s Disease Society Brain Bank diagnostic criteria.
2. Diagnosis of probable PD dementia (PDD) according to the Movement Disorder Society Task Force clinical diagnostic criteria.
3. Montreal Cognitive Assessment (MoCA) score of 13 to 23, inclusive, at Screening.
4. Male or female and aged ≥ 50 years.
5. Caregivers and subjects (or legal representative) must understand and have signed approved informed consent.
6. Caregivers and subjects (or legal representative) must be able to understand study requirements and be willing to follow instructions.
7. 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.
8. 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.
9. 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.
10. Contraception:
o 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.
o 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.
Note: For men and women, acceptable methods of contraception include use of a condom with spermicide or use of oral, implantable or injectable contraceptives, or IUD, or a diaphragm with spermicide or diaphragm with condom.

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