Not provided
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Parent study failed to meet the primary endpoint and there were no treatment effects that favored AL002 on secondary clinical and functional endpoints.
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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
Not provided
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL002 Dose 1 | Experimental | AL002 every 4 weeks |
|
| AL002 Dose 2 | Experimental | AL002 every 4 weeks |
|
| AL002 Dose 3 | Experimental | AL002 every 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL002 | Drug | Administered via intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
Not provided
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Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| TBD TBD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Alzheimer's Institute | Phoenix | Arizona | 85006 | United States | ||
| Georgetown University Medical Center |
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
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AL002 15 mg/kg | Subjects are receiving 15 mg/kg of AL002 every 4 weeks |
| FG001 | AL002 40 mg/kg | Subjects are receiving 40 mg/kg of AL002 every 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 12, 2024 | Dec 2, 2025 |
Not provided
Not provided
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| 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. | 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. | 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 |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| SFM Clinical Research, LLC | Boca Raton | Florida | 33487 | United States |
| Charter Research | Lady Lake | Florida | 32159 | United States |
| K2 Medical Research - Maitland | Maitland | Florida | 32751 | United States |
| Progressive Medical Research - ClinEdge - PPDS | Port Orange | Florida | 32127 | United States |
| Axiom Brain Health LLC | Tampa | Florida | 33609 | United States |
| "Alzheimers Research and Treatment Center-Wellington " | Wellington | Florida | 33449 | United States |
| Conquest Research LLC - Winter Park - ClinEdge - PPDS | Winter Park | Florida | 32819 | United States |
| Hattiesburg Clinic | Hattiesburg | Mississippi | 39401 | United States |
| Advanced Clinical Institute | Neptune City | New Jersey | 07753 | United States |
| Feinstein Institute For Medical Research | Manhasset | New York | 11030 | United States |
| SUNY Upstate Medical Center | Syracuse | New York | 13210 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| Summit Research Network | Portland | Oregon | 97210 | United States |
| Instituto Privado Kremer | Córdoba | Córdoba Province | X5004AOA | Argentina |
| Centro de Psiquiatria Biologica | Mendoza | Mendoza Province | 05500 | Argentina |
| KaRa Institute of Neurological Disease | Macquarie Park | New South Wales | 2113 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Alfred Health | Melbourne | Victoria | 3004 | Australia |
| Kawartha Regional Memory Clinic | Peterborough | Ontario | K9H 2P4 | Canada |
| Baycrest Health Sciences | Toronto | Ontario | M6A 2X8 | Canada |
| Universitätsklinikum Ulm-Oberer Eselsberg 45 | Ulm | Baden-Wurttemberg | 89081 | Germany |
| Klinikum rechts der Isar der Technischen Universitaet Muenchen | Munich | Bavaria | 81675 | Germany |
| Ambulantes Gesundheitszebtrum der Charite GmbH | Berlin | State of Berlin | 12200 | Germany |
| Charité - Universitätsmedizin Berlin | Berlin | State of Berlin | 13125 | Germany |
| Fondazione Policlinico Universitario A Gemelli-Rome | Rome | Lazio | 00168 | Italy |
| Azienda Policlinico Umberto | Rome | Lazio | 00185 | Italy |
| Ospedale Isola Tiberina - Gemelli Isola | Rome | Lazio | 00186 | Italy |
| ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN | Brescia | Lombardy | 25123 | Italy |
| IRCCS - Centro S. Giovanni di Dio Fatebene fratelli | Brescia | Lombardy | 25125 | Italy |
| Fondazione IRCCS CÃ Granda Ospedale Maggiore Policlinico | Milan | Lombardy | 20122 | Italy |
| Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3 | Milan | Lombardy | 20133 | Italy |
| Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena | Modena | Modena | 41126 | Italy |
| ASL Biella - Ospedale degli Infermi | Ponderano | Piedmont | 13875 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Italy |
| Brain Research Center Den Bosch - PPDS | 's-Hertogenbosch | North Brabant | 5223 LA | Netherlands |
| NZOZ Wroclawskie Centrum Alzheimerowskie | Wroclaw | Lower Silesian Voivodeship | 53-110 | Poland |
| Centrum Medyczne NeuroProtect | Warsaw | Masovian Voivodeship | 01-684 | Poland |
| EUROMEDIS Sp. z o.o. | Szczecin | West Pomeranian Voivodeship | 70-111 | Poland |
| Hospital de La Santa Creu i Sant Pau | Barcelona | Barcelona | 08025 | Spain |
| Fundacion ACE Instituto Catalan de Neurociencias-Gran via de Carles III, 85 bis | Barcelona | Barcelona | 8028 | Spain |
| Fundacion CITA Alzheimer Fundazioa | San Sebastián | Guipúzcoa | 20009 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | Madrid | 28034 | Spain |
| Hospital Universitario Doctor Peset | Valencia | Valencia | 46017 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | Valencia | 46026 | Spain |
| Centro De Atencion Especializada Oroitu | Getxo | Vizcaya | 48993 | Spain |
| Hospital Viamed Montecanal | Zaragoza | Zaragoza | 50012 | Spain |
| Re-Cognition Health - Bristol | Bristol | Bristol | BS32 4SY | United Kingdom |
| RE: Cognition Health - Plymouth | Plymouth | Devon | PL6 8BT | United Kingdom |
| Re:Cognition Health - Guildford - PPDS | Guildford | Surrey | GU2 7YD | United Kingdom |
| Re:Cognition Health | London | W1G 9RU | United Kingdom |
| The National Hospital for Neurology and Neurosurgery | London | WC1N 3BG | United Kingdom |
| NeuroClin Glasgow | Motherwell | ML1 4UF | United Kingdom |
| FG002 | AL002 60 mg/kg | Subjects are receiving 60 mg/kg of AL002 every 4 weeks |
| FG003 | Titration Cohort | The titration cohort will receive an initial starting dose of 6 mg/kg that will be increased to the target dose of 60 mg/kg. The subject will receive two doses of 6 mg/kg (Day 1/Week 1 and Week 5). The subject will receive two doses of 15 mg/kg (Week 9 and Week 13). The subject will receive two doses of 40 mg/kg (Week 17 and Week 21). Lastly, the subject will receive a dose of 60 mg/kg for the remainder of the study (Week 25 through the final dosing visit) |
| COMPLETED |
|
| NOT COMPLETED |
|
The analysis set used for demography and the baseline characteristics was the full analysis set. This includes all participants who were randomly assigned to study treatment in the parent study and received any amount of study treatment and were non-e4/e4. Since the full analysis set was used, the numbers for demographics and baseline characteristics is higher than that of the participant flow.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AL002 15 mg/kg | Subjects are receiving 15 mg/kg of AL002 every 4 weeks |
| BG001 | AL002 40 mg/kg | Subjects are receiving 40 mg/kg of AL002 every 4 weeks |
| BG002 | AL002 60 mg/kg | Subjects are receiving 60 mg/kg of AL002 every 4 weeks |
| BG003 | Titration Cohort | The titration cohort will receive an initial starting dose of 6 mg/kg that will be increased to the target dose of 60 mg/kg. The subject will receive two doses of 6 mg/kg (Day 1/Week 1 and Week 5). The subject will receive two doses of 15 mg/kg (Week 9 and Week 13). The subject will receive two doses of 40 mg/kg (Week 17 and Week 21). Lastly, the subject will receive a dose of 60 mg/kg for the remainder of the study (Week 25 through the final dosing visit) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The number of study participants by age category | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | The number of study participants based on sex | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | The number of study participants based on race | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | The number of study participants based on ethnicity | Count of Participants | Participants |
| |||||||||||||||
| Age, Customized | The mean age of the study participants | Mean | Standard Deviation | Years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Occurrence of Adverse Event | From the Screening period and throughout the treatment period until the end of study participation, up to 49 weeks. |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | 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. | Posted | Number | Occurrence of Adverse Event | From the Screening period and throughout the treatment period until the end of study participation, up to 49 weeks. |
| ||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Posted | Number | Occurrence of Abnormal Findings | From the Screening period and throughout the treatment period until the end of study completion, up to 49 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Posted | Number | Number of Participants | From the Screening period and throughout the treatment period until the end of the study participation up to 49 weeks. |
| ||||||||||||||||||||||||||||||||||||||
| Primary | 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. | The analysis population for this outcome includes the parent study and the long term extension. | Posted | Number | Number of Participants | 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 |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | The analysis population for this outcome includes the parent study and the long term extension. | Posted | Number | Number of Participants | 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 |
|
Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AL002 15 mg/kg | Subjects are receiving 15 mg/kg of AL002 every 4 weeks | 0 | 41 | 0 | 41 | 16 | 41 |
| EG001 | AL002 40 mg/kg | Subjects are receiving 40 mg/kg of AL002 every 4 weeks | 0 | 49 | 0 | 49 | 12 | 49 |
| EG002 | AL002 60 mg/kg | Subjects are receiving 60 mg/kg of AL002 every 4 weeks | 1 | 43 | 3 | 43 | 33 | 43 |
| EG003 | Titration Cohort | The titration cohort will receive an initial starting dose of 6 mg/kg that will be increased to the target dose of 60 mg/kg. The subject will receive two doses of 6 mg/kg (Day 1/Week 1 and Week 5). The subject will receive two doses of 15 mg/kg (Week 9 and Week 13). The subject will receive two doses of 40 mg/kg (Week 17 and Week 21). Lastly, the subject will receive a dose of 60 mg/kg for the remainder of the study (Week 25 through the final dosing visit) | 0 | 64 | 9 | 64 | 30 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic Reaction | Immune system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Clavicle Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Plasma Cell Myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
| |
| Amyloid-related Imaging Abnormality: Microhaemorrhages and Haemosiderin Deposits | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Cerebral Infarction | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Macular Degeneration | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Cystoid Macular Oedema | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Detachment of Macular Retinal Pigment Epithelium | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Neovascular Age-related Macular Degeneration | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pseudophakia | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Retinal Artery Embolism | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Visual Acuity Reduced | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Vitreous Floaters | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Toothache | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Vulvovaginal Mycotic Infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Infusion-related Reaction | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Alcohol Poisoning | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Radius Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Amylase Increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Blood Cholesterol Increases | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Blood Triglycerides Increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| C-Reactive Protein Increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Coagulation Test Abnormal | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Columbia-Suicide Severity Rating Scale Abnormal | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hepatic Enzyme Increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dyslipidemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hyperhomocystenaemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Plasma Cell Myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
|
Alector's agreements with principal investigators may vary but will not prohibit any investigator from publishing. Alector supports the publication of the results from all centers in a multi-center trial, and its agreements include provisions to enable the multi-center publication to occur before publication of data from a single site.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alector Medical Information | Alector | 650-826-2454 | medinfo@alector.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 20, 2024 | Dec 22, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| TEAE: Severe |
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| TEAE: Moderate |
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| TEAE: Mild |
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| Treatment-Related TEAE: Death |
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| Treatment-Related TEAE: Severe |
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| Treatment-Related TEAE: Moderate |
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| Treatment-Related TEAE: Mild |
|
|
|
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|
The titration cohort will receive an initial starting dose of 6 mg/kg that will be increased to the target dose of 60 mg/kg. The subject will receive two doses of 6 mg/kg (Day 1/Week 1 and Week 5). The subject will receive two doses of 15 mg/kg (Week 9 and Week 13). The subject will receive two doses of 40 mg/kg (Week 17 and Week 21). Lastly, the subject will receive a dose of 60 mg/kg for the remainder of the study (Week 25 through the final dosing visit) |
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|
| OG003 | Titration Cohort | The titration cohort will receive an initial starting dose of 6 mg/kg that will be increased to the target dose of 60 mg/kg. The subject will receive two doses of 6 mg/kg (Day 1/Week 1 and Week 5). The subject will receive two doses of 15 mg/kg (Week 9 and Week 13). The subject will receive two doses of 40 mg/kg (Week 17 and Week 21). Lastly, the subject will receive a dose of 60 mg/kg for the remainder of the study (Week 25 through the final dosing visit) |
|
|
| OG003 | Titration Cohort | The titration cohort will receive an initial starting dose of 6 mg/kg that will be increased to the target dose of 60 mg/kg. The subject will receive two doses of 6 mg/kg (Day 1/Week 1 and Week 5). The subject will receive two doses of 15 mg/kg (Week 9 and Week 13). The subject will receive two doses of 40 mg/kg (Week 17 and Week 21). Lastly, the subject will receive a dose of 60 mg/kg for the remainder of the study (Week 25 through the final dosing visit) |
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