Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer`s Disease. - ND
- Conditions
- Prodromal Alzheimer’s Disease.MedDRA version: 9.1Level: LLTClassification code 10066571
- Registration Number
- EUCTR2010-019895-66-IT
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 372
1. Written consent signed by the subject (co-signed by the subject’s next of kin or study partner, if required by the local regulations/guidelines/EC/IRB). 2. Age: 50-80. 3. Males or females of non-childbearing potential (more than two years after the cessation of menses or surgically sterile by means of hysterectomy, bilateral oopherectomy or tubal ligation). Additional blood tests will be done if required by the local regulations/guidelines/EC/IRB for further confirmation of non-childbearing potential. 4. Has a study partner who in the investigator`s judgment is able to provide accurate information as to the subject`s cognitive and functional abilities, who agrees to provide information at clinic visits which require partner input for scale completion, and who signs the necessary consent form if applicable. 5. Fluent in the language of the tests used at the study site. 6. Has had sufficient education or work experience to exclude mental retardation. 7. Willing to complete all aspects of the study (including MRI, lumbar puncture and genotyping) and capable of doing so either alone or with the help of the study partner 8. Not currently being treated with approved marketed medications for AD and the study physician does not anticipate any treatment with one during the study. 9. If not already aware, willing to have their ApoE genotype status withheld until the study is unblinded unless required by the relevant health authority or EC/IRB. If informing the subject of their ApoE status is required, the informed consent may be reviewed and re-signed before treatment begins. 10. Visual and auditory acuity sufficient to perform the cognitive tests (Eye glasses and hearing aids are permitted.) 11. Agree not to donate blood or blood products for transfusion for the duration of the study and for one year after final dose. Et al..
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
CNS Disorders: 1. Other prior or current neurologic or medical disorder which may currently or during the course of the study impair cognition or psychiatric functioning including but not limited to: head trauma, seizure disorder, neurodegenerative disease, hydrocephalus, cerebral / spinal hematoma, inflammatory disease, CNS infection (e.g. encephalitis or meningitis), neoplasm, toxic exposure, metabolic disorder (including hypoxic or hypoglycemic episodes) or endocrine disorder. 2. A history of stroke. 3. A documented history of TIA within the last 12 months. 4. History of schizophrenia, schizoaffective disorder or bipolar disorder 5. Currently meets criteria for major depression. 6. Any other psychiatric condition/disorder which could significantly interfere with the subject’s cooperative participation (e.g., prominent anxiety, agitation or behavioral problems). 7. Current evidence or history of substance abuse disorder (DSM-IV) within 2 years. Imaging related criteria: 8. As assessed by the central reader, MRI evidence of a) more than one lacunar infarct, b) territorial infarct or macroscopic hemorrhage, or c) any deep white matter lesion corresponding to an overall Fazekas score of 3 which requires at least 1 confluent hyperintense lesion on the FLAIR sequence which is 20 mm or greater in any dimension 9. The combined number of microbleeds and areas of leptomeningeal hemosiderosis on MRI is more than 2 on a 1.5T machine or more than 3 on a 3T machine based on the review done by the central reader. 10. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would contraindicate an MRI scan. Cardiovascular Disorders: 11. History of atrial fibrillation except if only one episode which resolved more than three years ago and for which treatment is no longer indicated. 12. Within the last 2 years, unstable or clinically significant cardiovascular disease (e.g. myocardial infarction, angina pectoris, NYHA Class II or more cardiac failure). 13. Any single QTcF above 470 msec, or a difference of more than 30 msec in QTcF between triplicate ECGs at screening; clinically relevant abnormalities on screening ECG based on centralized reading (e.g., QRS equal or longer than 120 msec; multifascicular block; AV block II). 14. Uncontrolled hypertension (i.e. blood pressure generally >160 systolic or >95 mmHg diastolic). Et al...
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