Study of SPG302 in Adult Participants With Mild-to-Moderate Alzheimer's Disease (AD)
Фаза 2 – изследване на ефективността и дозировката
Заболявания:
Alzheimer Disease
Спонсор: Spinogenix
Налично на:
БГ
Обобщение
This phase 2 study will evaluate the safety, tolerability, clinical efficacy, pharmacokinetics, and pharmacodynamics of SPG302 in adult participants with mild-to-moderate AD.
Описание
This is a phase 2, multicenter study to assess the safety, tolerability, CNS effects, pharmacokinetics, pharmacodynamics and clinical efficacy of SPG302 in adult participants with mild-to-moderate AD. The study will consist of 2 parts:
Part A: Placebo-controlled, randomized, safety and preliminary efficacy cohort with daily dosing for 28 day cycles
Part B: a randomized expansion cohort of daily dosing for 28 day cycles
Кой може да участва
Inclusion Criteria:
* Age 45-85
* Diagnosis of mild to moderate AD
* Clinical laboratory values within normal range or \< 1.5 times ULN
* If receiving AD-specific treatment, have been on stable dose for ≥ 3 months prior to first dose of study drug.
* Life expectancy of \>2 years
* Able and willing to provide written informed consent
Exclusion Criteria:
* Any physical or psychological condition that prohibits study completion
* Known cardiac disease
* Active or history of malignancy in the past 5 years
* Serious infection that will not be resolved by first day of study intervention.
* History of clinically significant CNS event or diagnosis in the past 5 years.
* Acute illness within 30 days of Day 1
* History of suicidal behavior or suicidal ideation
* History of chronic alcohol use or substance abuse in the last 5 years
* HIV, hepatitis B and/or hepatitis C positive
* Vaccines within 14 days
* Receipt of investigational products within 30 days
* Blood donation within 30 days
* Pregnant or breastfeeding