Treatment Period: Year 1 and 2
Visit 1 (Week 1)
It is anticipated that Day 1 of this study will occur on the same day as Week 76 of the PROGRESS-AD Study. Assessments common across both studies will only need to be done once.
If it is not possible to complete Day 1 on the same day as Week 76, a window of +14 days is permitted. Assessments performed as part of Week 76 do not need to be repeated unless medically indicated. These assessments are indicated by an (*).
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 2 (Week 4)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 3 (Week 8)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 4 (Week 12)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 5 (Week 16)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 6 (Week 20)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 7 (Week 24)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 8 (Week 28)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 9 (Week 32)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 10 (Week 36)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 11 (Week 40)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 12 (Week 44)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 13 (Week 48)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 14 (Week 52)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 15 (Week 56)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 16 (Week 60)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 17 (Week 64)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 18 (Week 68)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 19 (Week 72)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 20 (Week 76)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 21 (Week 80)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 22 (Week 84)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 23 (Week 88)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 24 (Week 92)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 25 (Week 96)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 26 (Week 100)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Visit 27 (Week 104)
Allowed interval ± 7 days, and consecutive dosing visits must be 3 to 5 weeks apart.
Early Study Discontinuation
At the time of withdrawing from the study.
Visit 28 (Week 112; Follow-up)
12 weeks after the final dose at Week 100 or 8 weeks after Week 104 if study treatment has been discontinued early.
Table of Abbreviations
| Abbreviation | Definition |
|---|---|
| ADAS-Cog14 | Alzheimer’s Disease Assessment Scale-Cognitive Subscale |
| ADCS-ADL-MCI | Alzheimer's Disease Cooperative Study-Activities of Daily Living for Mild Cognitive Impairment |
| AE | Adverse event |
| BP | Blood pressure |
| CDR | Clinical Dementia Rating |
| COA | Clinical outcome assessments |
| CSF | Cerebrospinal fluid |
| CV | Cardiovascular |
| d | days |
| eCRF | electronic case report form |
| ECG | Electrocardiogram |
| FSH | Follicular stimulating hormone |
| HIV | Human immunodeficiency virus |
| ICF | Informed consent form |
| IV | Intravenous |
| LLN | Lower limit of normal |
| LP | Lumbar puncture |
| MMSE | Mini-Mental State Exam |
| MRI | Magnetic resonance imaging |
| OLE | Open label extension |
| PD | Pharmacodynamics |
| PGRN | Progranulin |
| PK | Pharmacokinetics |
| PT | Prothrombin time |
| SAE | Serious adverse event |
| TSH | Thyroid stimulating hormone |
| ULN | Upper limit of normal |
| WOCBP | Women of childbearing potential |