A long-term extension study to evaluate the safety, tolerability, and efficacy of AL002 in participants with Early Alzheimer's Disease.
This is a Phase 2, parallel-group, long-term extension (LTE), dose-blind study to evaluate the long-term safety and efficacy of AL002 in participants with Early Alzheimer's Disease. The study is a multicenter, global trial that will enroll participants who completed the planned treatment period in AL002-2 (parent study).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
197
Administered via intravenous (IV) infusion
Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs).
Adverse Events are any untoward medical occurrence in a participant enrolled in this study, including side effects, injury, toxicity, sensitivity reaction, intercurrent illnesses, clinically significant physical exam signs, or sudden death, whether or not it is considered related to the study drug.
Time frame: From the Screening period and throughout the treatment period until the end of study participation, up to 49 weeks.
Safety and Tolerability as Measured by Number of Adverse Events of Special Interest and Serious Adverse Events
Adverse Events are any untoward medical occurrence in a participant enrolled in this study, including side effects, injury, toxicity, sensitivity reaction, intercurrent illnesses, clinically significant physical exam signs, or sudden death, whether or not it is considered related to the study drug.
Time frame: From the Screening period and throughout the treatment period until the end of study participation, up to 49 weeks.
Safety and Tolerability as Measured by the Number of Cases of Abnormal Vital Signs, Clinical Laboratory Results and Findings From Physical, Neurological, Ophthalmological Examinations and Electrocardiograms.
Evaluation of vital signs (blood pressure, pulse, temperature), clinical laboratory results (hematology, biochemistry, urinalysis), and findings from physical, neurological, ophthalmological examinations, and electrocardiograms.
Time frame: From the Screening period and throughout the treatment period until the end of study completion, up to 49 weeks
To Evaluate the Long-term Safety and Tolerability of AL002, by Assessing the Number of Suicidal Risk Events Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Two versions of the C-SSRS were used in the parent study: a Screening/Baseline version and a Since Last Visit version. The Screening/Baseline version of the C-SSRS assesses the lifetime suicidal ideation and behavior and non-suicidal self-injurious behavior, the suicidal ideation in the past 6 months, and suicidal behavior and non-suicidal self-injurious behavior in the past two years. The C-SSRS uses a point scale where a higher score indicates a greater risk of suicidality.
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Banner Alzheimer's Institute
Phoenix, Arizona, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
SFM Clinical Research, LLC
Boca Raton, Florida, United States
Charter Research
Lady Lake, Florida, United States
K2 Medical Research - Maitland
Maitland, Florida, United States
Progressive Medical Research - ClinEdge - PPDS
Port Orange, Florida, United States
Axiom Brain Health LLC
Tampa, Florida, United States
"Alzheimers Research and Treatment Center-Wellington "
Wellington, Florida, United States
Conquest Research LLC - Winter Park - ClinEdge - PPDS
Winter Park, Florida, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
...and 44 more locations
Time frame: From the Screening period and throughout the treatment period until the end of the study participation up to 49 weeks.
To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-E by Assessing the Number of Participants With ARIA-E Events
Among the brain abnormalities detected on MRI are ARIA, which are believed to reflect leakage of proteinaceous fluid or other blood products in the leptomeninges or brain parenchyma. The term ARIA was originally coined to describe specific brain abnormalities seen on MRI in anti-amyloid clinical trials. Specifically, according to the convention developed to describe ARIA occurring in clinical trials of anti-amyloid immunotherapies, ARIA-E refers to MRI findings of vasogenic edema and leptomeningeal/sulcal effusion.
Time frame: Screening, Week 9, Week 17, Week 25, Week 33, Week 41, End of Study visit, and Early Termination visit, if applicable up to 49 weeks
To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-H by Assessing the Number of Participants With ARIA-H Events
Among the brain abnormalities detected on MRI are ARIA, which are believed to reflect leakage of proteinaceous fluid or other blood products int the leptomeninges or brain parenchyma. The term ARIA was originally coined to describe specific brain abnormalities seen on MRI in anti-amyloid clinical trials. Specifically, according to the convention developed to describe ARIA occurring in clinical trials of anti-amyloid immunotherapies, ARIA-H refers to MRI findings of cerebral microhemorrhages, leptomeningeal hemosiderosis, and cerebral macrohemorrhages.
Time frame: Screening, Week 9, Week 17, Week 25, Week 33, Week 41, End of Study visit, and Early Termination visit, if applicable up to 49 weeks