A Clinical Trial to evaluate AL002 in Participants with early Alzheimer's Disease
- Conditions
- Early Alzheimer’s DiseaseTherapeutic area: Diseases [C] - Nervous System Diseases [C10]MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
- Registration Number
- EUCTR2019-001476-11-IT
- Lead Sponsor
- Alector Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 265
1.PT (PT) has any evidence of a condition other than AD that may affect cognition 2.PT has history or presence of vascular disease that has the potential to affect cognitive function, or stroke within past 2 years, or ischemic attack within last 6 months 3.PT has history of severe, clinically significant CNS trauma, or history or presence of intracranial tumor, or presence of infections that affect brain function or history of infections with neurologic sequelae 4.PT has history or presence of systemic autoimmune disorders that potentially cause progressive neurologic disease with associated cognitive deficits, or uveitis with medical intervention, chronic inflammatory or degenerative condition of the eye, current eye infection, any ongoing eye disorder requiring injectable medical therapy or planned invasive eye procedure during the study period 5.PT has history of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder, or is at risk of suicide in the PI´s opinion 6.PT has history of alcohol and/or substance use disorder within the past 2 years 7.PT has MRI evidence of a. >2 lacunar infarcts. b. Any territorial infarct >1 cm3. c. Any white matter lesion as per protocol 8.PT has presence on MRI of microbleeds and areas of leptomeningeal hemosiderosis as per protocol 9.PT has presence of significant cerebral vascular pathology, or any cortical stroke regardless of age as assessed by the MRI central reader 10.PT is unable to tolerate MRI procedures or has a contraindication 11.PT has uncontrolled hypertension or has a history or presence of an abnormal ECG 12.PT has history of ventricular dysrhythmias or risk factors for ventricular dysrhythmias 13.PT has significant kidney disease as per protocol 14.PT has impaired hepatic function as per protocol 15.PT is positive for hepatitis B surface Ag, total hepatitis B core antibody, HIV-1 or -2 antibodies or antigen, or history of spirochetal infection of the CNS. PTs with a positive hepatitis C virus antibody will be allowed if hepatitis C RNA is negative 16.PTs with active or latent TB disease should not be enrolled in the trial 17. Any chronic active immune disorder requiring systemic immunosuppressive therapy within 1 year prior to study enrollment 18.PT has abnormal screening thyroid function tests 19.PT has screening folic acid or low vitamin B12 levels that may be contributing to cognitive impairment 20.PT has screening hemoglobin A1c >8% or poorly controlled insulin dependent diabetes 21.PT has deformity of the lumbosacral region of the spine that in the PI´s opinion would contraindicate LP in those who can only be CSF eligible due to regional lack of availability of PET ligands, or in those who are in Part 1 22.PT has clinically significantly abnormal screening blood or urine results that remain abnormal, or has impaired coagulation 23.PT has history of cancer except:a. Is clinically cured.b. Is not being actively treated and is not likely to require treatment in next 3 years.c. Low probability of recurrence d. Prostate cancer, without progression in the past 2 years 24.PT has known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins 25.PT with other severe or unstable medical condition that could put PT at special risk 26.PT resides in a skilled nursing facility, convalescent home, or long-term care facility 27.Takes any medications known to impair consciousness or cognit
1.Participant (PT) has any evidence of a condition other than AD that may affect cognition 2.PT has history or presence of vascular disease that has the potential to affect cognitive function, or stroke within past 2 years, or ischemic attack within last 6 months 3.PT has history of severe, clinically significant CNS trauma, or history or presence of intracranial tumor, or presence of infections that affect brain function or history of infections with neurologic sequelae 4.PT has history or presence of systemic autoimmune disorders that potentially cause progressive neurologic disease with associated cognitive deficits, or uveitis with medical intervention, chronic inflammatory or degenerative condition of the eye, current eye infection, any ongoing eye disorder requiring injectable medical therapy or planned invasive eye procedure during the study period 5.PT has history of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder, or is at risk of suicide in the PI´s opinion 6.PT has history of alcohol and/or substance use disorder within the past 2 years 7.PT has MRI evidence of a. >2 lacunar infarcts. b. Any territorial infarct >1 cm3. c. Any white matter lesion as per protocol 8.PT has presence on MRI of microbleeds and areas of leptomeningeal hemosiderosis as per protocol 9.PT has presence of significant cerebral vascular pathology, or any cortical stroke regardless of age as assessed by the MRI central reader 10.PT is unable to tolerate MRI procedures or has a contraindication 11.PT has uncontrolled hypertension or has a history or presence of an abnormal ECG 12.PT has history of ventricular dysrhythmias or risk factors for ventricular dysrhythmias 13.PT has significant kidney disease as per protocol 14.PT has impaired hepatic function as per protocol 15.PT is positive for hepatitis B surface Ag, total hepatitis B core antibody, HIV-1 or -2 antibodies or antigen, or history of spirochetal infection of the CNS. PTs with a positive hepatitis C virus antibody will be allowed if hepatitis C RNA is negative 16.PTs with active or latent TB disease should not be enrolled in the trial 17. Any chronic active immune disorder requiring systemic immunosuppressive therapy within 1 year prior to study enrollment 18.PT has abnormal screening thyroid function tests 19.PT has screening folic acid or low vitamin B12 levels that may be contributing to cognitive impairment 20.PT has screening hemoglobin A1c >8% or poorly controlled insulin dependent diabetes 21.PT has deformity of the lumbosacral region of the spine that in the PI´s opinion would contraindicate LP in those who can only be CSF eligible due to regional lack of availability of PET ligands, or in those who are in Part 1 22.PT has clinically significantly abnormal screening blood or urine results that remain abnormal, or has impaired coagulation 23.PT has history of cancer except:a. Is clinically cured.b. Is not being actively treated and is not likely to require treatment in next 3 years.c. Low probability of recurrence d. Prostate cancer, without progression in the past 2 years 24.PT has known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins 25.PT with other severe or unstable medical condition that could put PT at special risk 26.PT resides in a skilled nursing facility, convalescent home, or long-term care facility 27.Takes any medications known to impair consciousness
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method