Alzheimer's Disease MedDRA version: 15.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: MABT5102A
Product Code: MABT5102A
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: MABT5102A
Sponsors
Genentech Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General •Ability to provide written informed consent by the patient and a legally authorized health care representative for the patient •Ability and willingness of patient and a legally authorized health care representative to comply with the protocol’s requirements •Age 50-80 years •Body weight = 45 kg and = 120 kg •Adequate visual and auditory acuity in the investigator's judgment to allow for neuropsychological testing •Fluent in the language of the test assessments •Negative urine test for drugs of abuse (including medical marijuana) at screening •For female patients, a negative serum ß–human chorionic gonadotropin (ß-hCG) pregnancy test at screening •Normal thyroid-stimulating hormone (TSH) and vitamin B12 levels at screening •For male patients with partners with reproductive potential, agreement to use a reliable means of contraception (e.g., condoms) during the study •Availability of a person who can provide information on activities of daily living and behavior to complete the related assessments This person must live with the patient at least 4 days per week and be familiar with the overall function and behavior of the patient. Related to Neurology/Cognition •Diagnosis of probable AD according to the NINCDS-ADRDA criteria (McKhann et al. 1984) •MMSE score of 18-26 points at screening (Folstein et al. 1975) •GDS-15 score of =65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: General •Female patient with reproductive potential Female patients must either have undergone documented surgical sterilization or have not experienced menstruation for at least 12 consecutive months. •Severe or unstable medical condition that, in the investigator's or Sponsor's opinion, would interfere with the patient's ability to complete the study assessments or would require the equivalent of institutional or hospital care Related to Medical History/Conditions •History or presence of clinically evident vascular disease potentially affecting the brain (e.g., stroke, clinically significant carotid or vertebral stenosis or plaque, aortic aneurysm, intracranial aneurysm, cerebral hemorrhage, arteriovenous malformation) •Presence of more than two micro- or macrohemorrhages as assessed by T2* weighted GRE MRI •History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma (e.g., cerebral contusion) •History or presence of intracranial tumor (e.g., meningioma, glioma) •Presence of potential metabolic cause of dementia or encephalopathy (e.g., vitamin B12 deficiency, thyroid abnormalities) •History or presence of infections that affect the brain (e.g., syphilis, neuroborreliosis, viral or bacterial meningitis/encephalitis, HIV encephalopathy) •History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., multiple sclerosis, lupus erythematosus, anti-phospholipid antibody syndrome, Behçet disease) •History or presence of psychiatric disease other than AD that may affect cognition, including but not limited to clinically significant major psychiatric disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) (e.g. major depression, schizophrenia, bipolar disorder) •History or presence of a neurologic disease other than AD that may affect cognition, including but not limited to Parkinson’s disease, corticobasal degeneration, dementia with Lewy bodies, Creutzfeldt–Jakob disease, progressive supranuclear palsy, frontotemporal degeneration, Huntington’s disease, normal pressure hydrocephalus, and hypoxia •Presence of visual hallucinations, parkinsonism, chorea, eye movement abnormalities, dystonia, or gait disturbance suggestive of a non-AD diagnosis •History of seizures with the exception of childhood febrile seizures •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins •Known or suspected history of alcohol or drug abuse within the previous 5 years (DSM-IV criteria) Medical marijuana is allowed if stopped 3 months prior to screening. •Evidence of malignancies, acute infections, renal failure that requires dialysis, or other unstable medical disease •Hospitalization within 4 weeks prior to screening •History of atrial fibrillation •Thyroid disease unless euthyroid on treatment •Clinically significant laboratory or ECG abnormalities in the investigator’s judgement •Prolonged QTc interval (> 450 msec in males, > 470 m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: •To evaluate the efficacy of MABT5102A compared with placebo, when administered over 68 weeks to patients with mild to moderate AD, in inhibiting disease progression using a global assessment measure, the Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score; Main Objective: •To evaluate the efficacy of MABT5102A compared with placebo, when administered over 68 weeks to patients with mild to moderate AD, in inhibiting disease progression using the Alzheimer’s Disease Assessment Scale Cognitive Subscale (ADAS-Cog [12-item]) •To evaluate the safety and tolerability of MABT5102A compared with placebo when administered over 68 weeks to patients with mild to moderate AD ;Primary end point(s): The primary efficacy outcome measure is change in ADAS-Cog (12-item) score between baseline and Week 73. This will be used to estimate the difference in mean change from baseline in ADAS-Cog (12-item) score at Week 73 between MABT5102A- and placebo-treated patients. Analysis of covariance (ANCOVA) adjusting for ApoE4 status and MMSE score will be used to estimate the primary endpoint. | — |
Countries
Germany, Spain, United Kingdom
Contacts
Public ContactIldiko Balint
Quintiles Hungary Ltd
Outcome results
None listed