Alzheimer's Disease
Conditions
Brief summary
A long-term extension study to evaluate the safety, tolerability, and efficacy of AL002 in participants with Early Alzheimer's Disease.
Detailed description
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).
Interventions
DRUGAL002
Administered via intravenous (IV) infusion
Sponsors
Alector Inc.
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Completion of the Planned Treatment Period in the AL002-2 study. * The participant is willing and able to give informed consent. * Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a week
Exclusion criteria
* Participants deemed not able to provide consent or assent by the Investigator or by local regulations. * Participants who were prematurely and permanently discontinued from treatment in the parent study for safety reasons. * Participation deemed inappropriate per Investigator discretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs). | From the Screening period and throughout the treatment period until the end of study participation, up to 49 weeks. | 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. |
| Safety and Tolerability as Measured by Number of Adverse Events of Special Interest and Serious Adverse Events | From the Screening period and throughout the treatment period until the end of study participation, up to 49 weeks. | 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. |
| 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. | From the Screening period and throughout the treatment period until the end of study completion, up to 49 weeks | Evaluation of vital signs (blood pressure, pulse, temperature), clinical laboratory results (hematology, biochemistry, urinalysis), and findings from physical, neurological, ophthalmological examinations, and electrocardiograms. |
| 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) | From the Screening period and throughout the treatment period until the end of the study participation up to 49 weeks. | 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. |
| To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-E by Assessing the Number of Participants With ARIA-E Events | 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 | 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. |
| To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-H by Assessing the Number of Participants With ARIA-H Events | 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 | 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. |
Countries
Argentina, Australia, Canada, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORTBD TBD
Participant flow
Recruitment details
This was a long term extension to the AL002-2 parent study, where participants were required to complete the planned treatment period in AL002-2.
Pre-assignment details
Participants received AL002 at final doses of 15 mg/kg, 40 mg/kg, or 60 mg/kg in the parent study. Participants who were randomized to active treatment in the parent study (Study AL002-2) remained at their previously assigned dose during this long-term extension study. Participants who were randomized to the placebo group in the parent study (Study AL002-2) were enrolled into the Titration Cohort
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 260 Participants |
| Age, Categorical Between 18 and 65 years | 72 Participants |
| Age, Customized Mean age of the study participants | 69.7 Years STANDARD_DEVIATION 8.26 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 80 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 49 | 1 / 43 | 0 / 64 |
| other Total, other adverse events | 16 / 41 | 12 / 49 | 33 / 43 | 30 / 64 |
| serious Total, serious adverse events | 0 / 41 | 0 / 49 | 3 / 43 | 9 / 64 |
Outcome results
None listed