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- | AL002 / Alector, AbbVie
Biomarker, Clinical, Journal: Developing Topics. (Pubmed Central) - Jan 12, 2025
The prototype VR-PrecivityAD blood-test was highly predictive of amyloid positivity, confirmed by VR-PET or CSF, among INVOKE-2 screening subjects. Use of a lower VR-APS threshold was associated with fewer false negatives without a meaningful increase in false positives when compared to the standard CL-PrecivityAD threshold in the INVOKE-2 screening population.
- | AL002 / Alector, AbbVie
Biomarker, Clinical, Journal: Developing Topics. (Pubmed Central) - Jan 12, 2025
Use of a lower VR-APS threshold was associated with fewer false negatives without a meaningful increase in false positives when compared to the standard CL-PrecivityAD threshold in the INVOKE-2 screening population. Taken together, the baseline characteristics data for the INVOKE-2 study represent a study population that enables testing of the effects of a TREM2 agonist in early AD.
- || AL002 / Alector, AbbVie
Enrollment closed: A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease (clinicaltrials.gov) - Sep 25, 2024
P2, N=188, Active, not recruiting, Sponsor: Alector Inc.
Taken together, the baseline characteristics data for the INVOKE-2 study represent a study population that enables testing of the effects of a TREM2 agonist in early AD. Recruiting --> Active, not recruiting
- |||| AL002 / Alector, AbbVie
Trial completion: INVOKE-2: A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - Sep 19, 2024
P2, N=381, Completed, Sponsor: Alector Inc.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- | AL002 / Alector, AbbVie
Journal: Trem2 Agonist Reprograms Foamy Macrophages to Promote Atherosclerotic Plaque Stability. (Pubmed Central) - Jun 26, 2024
In vitro studies validated that Trem2 agonism with AL002a promoted foamy macrophage oxidized low-density lipoprotein uptake, survival, and cholesterol efflux. Trem2 agonism expands atherosclerotic plaque macrophages by promoting cell survival and proliferation but improves features of plaque stability by rewiring foamy macrophage function to enhance cholesterol efflux and collagen deposition.
- AL002 / Alector, AbbVie
Use of a blood-based amyloid test for screening in INVOKE-2: a phase 2 randomized, double-blind, placebo-controlled study evaluating AL002 in early Alzheimer (Exhibit (Pennsylvania Convention Center); In-Person) - Jun 19, 2024 - Abstract #AAIC2024AAIC_3400;
The prototype VR-PrecivityAD blood-test was highly predictive of amyloid positivity, confirmed by VR-PET or CSF, among INVOKE-2 screening subjects. Use of a lower VR-APS threshold was associated with fewer false negatives without a meaningful increase in false positives when compared to the standard CL-PrecivityAD threshold in the INVOKE-2 screening population.
- AL002 / Alector, AbbVie
Baseline characteristics for INVOKE-2: a phase 2 randomized, double-blind, placebo-controlled study evaluating AL002 in early Alzheimer (Exhibit (Pennsylvania Convention Center); In-Person) - Jun 19, 2024 - Abstract #AAIC2024AAIC_1430;
Use of a lower VR-APS threshold was associated with fewer false negatives without a meaningful increase in false positives when compared to the standard CL-PrecivityAD threshold in the INVOKE-2 screening population. Taken together, the baseline characteristics data for the INVOKE-2 study represent a study population that enables testing of the effects of a TREM2 agonist in early AD.
- ||| AL002 / Alector, AbbVie
Enrollment closed: INVOKE-2: A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - Sep 6, 2023
P2, N=328, Active, not recruiting, Sponsor: Alector Inc.
Taken together, the baseline characteristics data for the INVOKE-2 study represent a study population that enables testing of the effects of a TREM2 agonist in early AD. Recruiting --> Active, not recruiting
- || AL002 / Alector, AbbVie
Trial completion date, Trial primary completion date: INVOKE-2: A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - Aug 9, 2023
P2, N=328, Recruiting, Sponsor: Alector Inc.
Recruiting --> Active, not recruiting Trial completion date: Jan 2024 --> Nov 2024 | Trial primary completion date: Dec 2023 --> Oct 2024
- AL002 / Alector, AbbVie
AL002c-mediated reduction in amyloid ? pathology is reflected by changes in plasma Alzheimer (In-Person) - Jul 6, 2023 - Abstract #AAIC2023AAIC_6401;
AL002c-associated changes in plasma A?42/40 and tau were consistent with a concomitant reduction in filamentous plaques and neurite dystrophy. 1 These results lend further support to the clinical utility of plasma A?42/40 as a marker for the reduction of neurotoxic amyloid plaques in clinical trials with AL002.
- AL002 / Alector, AbbVie
INVOKE-2: Phase 2 trial of a TREM2 mAb in Early AD (Hall 3) - Jul 6, 2023 - Abstract #AAIC2023AAIC_4879;
1 These results lend further support to the clinical utility of plasma A?42/40 as a marker for the reduction of neurotoxic amyloid plaques in clinical trials with AL002. The INVOKE-2 trial is an ongoing global Phase 2 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of AL002 in participants with early Alzheimer
- |||| AL002 / Alector, AbbVie
New P2 trial: A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease (clinicaltrials.gov) - Feb 27, 2023
P2, N=190, Recruiting, Sponsor: Alector Inc.
- |||| AL-002 / Alector, AbbVie
New P2 trial: A Clinical Trial to evaluate AL002 in Participants with early Alzheimer's Disease Ensayo cl (EUDRACT) - Feb 21, 2023
P2, N=190, Ongoing, Sponsor: Alector, Inc.
- ||||| AL-002 / Alector, AbbVie
Preclinical: .@NimanshaJ, @holtzman4 et al. (https://t.co/vr2CACMaIQ) find that chronic TREM2 activation by AL002a antibody increases neurite dystrophy in 5xFAD mice seeded w/ #Alzheimers disease tau. Insights from @CarlingGillian, Wenjie Luo & @LiGanLab: https://t.co/uq0mpkyZ81 (Twitter) - Dec 3, 2022
- |||| AL-002 / Alector, AbbVie
In @JExpMed, @CarlingGillian, Wenjie Luo & @LiGanLab @WeillCornell discuss study by @NimanshaJ, @holtzman4 et al. (https://t.co/AGy9TERiC4) showing that chronic TREM2 activation by AL002a antibody exacerbates the seeding and spread of pathological tau https://t.co/iLVTVe4FvT (Twitter) - Nov 18, 2022
- |||| AL-002 / Alector, AbbVie
.@CarlingGillian, Wenjie Luo & Li Gan @LiGanLab @WeillCornell discuss study by @NimanshaJ, @holtzman4 et al. (https://t.co/vr2CACMaIQ) showing that chronic TREM2 activation by AL002a antibody exacerbates the seeding and spread of pathological tau https://t.co/uq0mpkyZ81 (Twitter) - Nov 18, 2022
- AL-002 / Alector, AbbVie
A Phase 1 Study of AL002 in Healthy Volunteers (Poster Hall) - Mar 6, 2022 - Abstract #AAN2022AAN_3434;
AL002 treatment resulted in TREM2 target engagement and proof of activity in the CSF of HVs. These results have supported progressing AL002 to an ongoing Phase 2 study (INVOKE-2) to investigate its effects on cognitive decline and neurodegeneration in subjects with early AD.
- AL-002 / Alector, AbbVie
INVOKE-2 - A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AL002 in Participants with Early Alzheimer’s Disease (Poster Hall) - Mar 6, 2022 - Abstract #AAN2022AAN_2977;
P2
INVOKE-2 is designed to investigate the efficacy and safety of AL002, representing a novel, first-in-class neuro-immunological approach for treating AD. Enrollment is ongoing.
- || AL002 / Alector, AbbVie
Trial completion date, Trial primary completion date: INVOKE-2: A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - Feb 3, 2022
P2, N=265, Recruiting, Sponsor: Alector Inc.
Enrollment is ongoing. Trial completion date: Aug 2023 --> Jan 2024 | Trial primary completion date: Jun 2023 --> Dec 2023
- | AN1792 / J&J, Pfizer, AL-002 / Alector, AbbVie
Journal, IO biomarker: An Immunomodulatory Therapeutic Vaccine Targeting Oligomeric Amyloid-β. (Pubmed Central) - Sep 12, 2021
The E22W42 vaccine is possibly safer for patients with impaired immune systems. Since there is increasing evidence that oligomeric form of Aβ are the toxic species to neurons, the E22W42 antibody's specificity for these "oligomeric" Aβ species could provide the opportunity to produce some clinical benefits in AD subjects.
- AL-002 / Alector, AbbVie
[VIRTUAL] INVOKE-2 - A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AL002 IN PARTICIPANTS WITH EARLY ALZHEIMER’S DISEASE () - Aug 2, 2021 - Abstract #AAIC2021AAIC_1904;
P2
INVOKE-2 is designed to investigate the efficacy and safety of AL002, representing a novel, first-in-class neuro-immunological approach for treating AD. Enrollment is ongoing.
- AL-002 / Alector, AbbVie
[VIRTUAL] A Phase 1 Study of AL002 in Healthy Volunteers () - Aug 2, 2021 - Abstract #AAIC2021AAIC_1889;
AL002 treatment resulted in TREM2 target engagement and proof of activity in the CSF of HVs. These results have supported progressing AL002 to an ongoing Phase 2 study (INVOKE-2) to investigate its effects on cognitive decline and neurodegeneration in subjects with early AD.
- AL-002 / Alector, AbbVie
INVOKE-2 - A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AL002 IN PARTICIPANTS WITH EARLY ALZHEIMER’S DISEASE (Convention Ctr - Exhibit Hall F) - Aug 2, 2021 - Abstract #AAIC2021AAIC_1838;
P2
INVOKE-2 is designed to investigate the efficacy and safety of AL002, representing a novel, first-in-class neuro-immunological approach for treating AD. Enrollment is ongoing.
- AL-002 / Alector, AbbVie
A Phase 1 Study of AL002 in Healthy Volunteers (Convention Ctr - Exhibit Hall F) - Aug 2, 2021 - Abstract #AAIC2021AAIC_1833;
AL002 treatment resulted in TREM2 target engagement and proof of activity in the CSF of HVs. These results have supported progressing AL002 to an ongoing Phase 2 study (INVOKE-2) to investigate its effects on cognitive decline and neurodegeneration in subjects with early AD.
- | AL-002 / Alector, AbbVie
Journal: Therapeutic Trem2 activation ameliorates amyloid-beta deposition and improves cognition in the 5XFAD model of amyloid deposition. (Pubmed Central) - Jul 4, 2021
These results have supported progressing AL002 to an ongoing Phase 2 study (INVOKE-2) to investigate its effects on cognitive decline and neurodegeneration in subjects with early AD. These findings indicate that Trem2 activators may be effective for the treatment of AD and possibly other neurodegenerative disorders.
- || lecanemab (BAN2401) / Biogen, BioArctic, Eisai, AL003 / Alector, AbbVie, AL-002 / Alector, AbbVie
Review, Journal: A Path Toward Precision Medicine for Neuroinflammatory Mechanisms in Alzheimer's Disease. (Pubmed Central) - Mar 5, 2021
Robust biomarker-drug codevelopment pipelines are expected to enrich large-scale clinical trials testing new-generation compounds active, directly or indirectly, on neuroinflammatory targets and displaying putative disease-modifying effects: novel NSAIDs, AL002 (anti-TREM2 antibody), anti-Aβ protofibrils (BAN2401), and AL003 (anti-CD33 antibody). As a next step, taking advantage of breakthrough and multimodal techniques coupled with a systems biology approach is the path to pursue for developing individualized therapeutic strategies targeting neuroinflammation under the framework of precision medicine.
- | AL-002 / Alector, AbbVie
Journal: Anti-human TREM2 induces microglia proliferation and reduces pathology in an Alzheimer's disease model. (Pubmed Central) - Mar 3, 2021
We further showed that a variant of AL002c is safe and well tolerated in a first-in-human phase I clinical trial and engages TREM2 based on cerebrospinal fluid biomarkers. We conclude that AL002 is a promising candidate for AD therapy.
- AL-002 / Alector, AbbVie
[VIRTUAL] PK/PD MODEL OF THE EFFECTS OF AL002, AN ANTI-TREM2 ANTIBODY, FROM A FIRST-INHUMAN PHASE 1 STUDY () - Dec 24, 2020 - Abstract #ADPD2021ADPD_1041;
Diagnostic plots, including visual predictive checks, show the model was predictive of the data. The model was used to identify an intravenous (IV) regimen for a Phase 2 study that is predicted to activate microglia TREM2 signaling for sustained treatment periods.
- AL-002 / Alector, AbbVie
[VIRTUAL] ANTI-HUMAN TREM2 INDUCES MICROGLIA PROLIFERATION AND REDUCES PATHOLOGY IN AN ALZHEIMER’S DISEASE MODEL () - Dec 24, 2020 - Abstract #ADPD2021ADPD_1040;
The model was used to identify an intravenous (IV) regimen for a Phase 2 study that is predicted to activate microglia TREM2 signaling for sustained treatment periods. We conclude that AL002 is a promising candidate for AD therapy.
- ||| AL002 / Alector, AbbVie
Trial completion: A Phase I Study for Safety and Tolerability of AL002. (clinicaltrials.gov) - Dec 9, 2020
P1, N=69, Completed, Sponsor: Alector Inc.
We conclude that AL002 is a promising candidate for AD therapy. Active, not recruiting --> Completed
- |||| AL002 / Alector, AbbVie
Enrollment open: INVOKE-2: A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - Nov 17, 2020
P2, N=265, Recruiting, Sponsor: Alector Inc.
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- ||||| AL002 / Alector, AbbVie
New P2 trial: INVOKE-2: A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - Oct 18, 2020
P2, N=265, Not yet recruiting, Sponsor: Alector Inc.
- || AL002 / Alector, AbbVie
Enrollment closed, Trial completion date, Trial primary completion date: A Phase I Study for Safety and Tolerability of AL002. (clinicaltrials.gov) - Jul 9, 2020
P1, N=69, Active, not recruiting, Sponsor: Alector Inc.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial completion date: Mar 2020 --> Nov 2020 | Trial primary completion date: Dec 2019 --> Sep 2020
- AL-002 / Alector, AbbVie
A PHASE 1 STUDY OF AL002 IN HEALTHY VOLUNTEERS AND PATIENTS WITH MILD-TO- MODERATE ALZHEIMER’S DISEASE () - Oct 16, 2019 - Abstract #CTAD2019CTAD_69;
Recruiting --> Active, not recruiting | Trial completion date: Mar 2020 --> Nov 2020 | Trial primary completion date: Dec 2019 --> Sep 2020 To date AL002 has been seen to be generally safe and tolerable and is being considered for investigation in a proof-of-concept Phase 2 study
- ||| AL002 / Alector, AbbVie
Enrollment open: A Phase I Study for Safety and Tolerability of AL002. (clinicaltrials.gov) - Jan 30, 2019
P1, N=67, Recruiting, Sponsor: Alector Inc.
To date AL002 has been seen to be generally safe and tolerable and is being considered for investigation in a proof-of-concept Phase 2 study Not yet recruiting --> Recruiting
- | AL002 / Alector, AbbVie
New P1 trial: A Phase I Study for Safety and Tolerability of AL002. (clinicaltrials.gov) - Aug 17, 2018
P1, N=52, Not yet recruiting, Sponsor: Alector Inc.