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. 2021 Feb 14;7(1):e12123. doi: 10.1002/trc2.12123

TABLE 1.

AMARANTH and DAYBREAK‐ALZ study characteristics

Characteristic Timepoint BOTH STUDIES AMARANTH DAYBREAK‐ALZ
Phase 2/3 3
Indication

Early symptomatic AD

(MCI due to AD and mild AD dementia)

 Mild AD dementia
Clinicaltrials.gov identifier NCT02245737 NCT02783573
Treatment dose Lanabecestat 20 mg, 50 mg, or placebo once daily
Study duration 104 weeks; placebo‐controlled treatment 78 weeks; placebo‐controlled treatment
Total patients enrolled and randomized 2218 1722
Key inclusion criteria

  •  55 to 85 years old

  •  Mild AD: meet NIA‐AA criteria with a CDR‐GS of 0.5 or 1, with memory box score ≥0.5

  •  MMSE score 20‐30 (AMARANTH) or 20‐26 (DAYBREAK‐ALZ)

  •  Study partner

  • Must be amyloid positive, as measured by any of the following: CSF, florbetapir amyloid PET, historical amyloid PET

MCI: meet NIA‐AA criteria with a CDR‐global score of 0.5, with memory box score ≥0.5

RBANS DMI ≤85

 N/A
Key exclusion criteria

  •  Unstable medical conditions or medication use

  •  MRI: > 5 microhemorrhages, significant cerebrovascular pathology, or other pathologies

  •  QTcF > 470 ms

  • History of vitiligo/current evidence of post‐inflammatory hypopigmentation/depigmenting agents exposure
Neuroimaging assessments schedule Screening/Baseline

  •  Florbetapir PET imaging

  •  FDG PET imaging

  •  Flortaucipir PET imaging

  • MRI

  •  Florbetapir PET imaging

  •  Florbetapir perfusion PET imaging

  •  FDG PET imaging

  •  Flortaucipir PET imaging

  •  MRI
Week 39 N/A

  •  Flortaucipir PET imaging
Week 52

  •  Flortaucipir PET imaging

  • MRI

 N/A
Week 78 N/A

  •  Florbetapir PET imaging

  •  Florbetapir perfusion PET

  •  FDG PET imaging

  •  Flortaucipir PET imaging

  • MRI
Week 104

  •  Florbetapir PET imaging

  •  FDG PET imaging

  •  Flortaucipir PET imaging

  • MRI

 N/A
Efficacy assessments schedule Screening/Baseline

  •  ADAS‐Cog13

  •  ADCS‐ADL

  •  MMSE

  •  FAQ

  • CDR

  •  ADAS‐Cog13

  •  ADCS‐ADL

  •  MMSE

  •  FAQ

  • CDR
Week 13

  •  ADAS‐Cog13

  • MMSE

  •  ADAS‐Cog13

  • MMSE
Week 26

  •  ADAS‐Cog13

  •  ADCS‐ADL

  •  MMSE

  •  FAQ

  • CDR

  •  ADAS‐Cog13

  •  ADCS‐ADL

  •  MMSE

  •  FAQ

  • CDR
Week 39 N/A

  • ADAS‐Cog13

Week 52

  •  ADAS‐Cog13

  •  ADCS‐ADL

  •  MMSE

  •  FAQ

  • CDR

  •  ADAS‐Cog13

  •  ADCS‐ADL

  •  MMSE

  •  FAQ

  • CDR
Week 65 N/A

  • ADAS‐Cog13

Week 78

  •  ADAS‐Cog13

  •  ADCS‐ADL

  •  MMSE

  •  FAQ

  • CDR

  •  ADAS‐Cog13

  •  ADCS‐ADL

  •  MMSE

  •  FAQ

  • CDR
Week 104

  •  ADAS‐Cog13

  •  ADCS‐ADL

  •  MMSE

  •  FAQ

  • CDR

 N/A

Abbreviations: AD, Alzheimer's disease; ADAS‐Cog13, 13‐item Alzheimer's Disease Assessment Scale‐Cognitive Subscale; ADCS‐ADL, Alzheimer's Disease Cooperative Study‐Activities of Daily Living Inventory; CDR, Clinical Dementia Rating; CSF, cerebrospinal fluid; FAQ, Functional Activities Questionnaire; FDG, fluorodeoxyglucose; MCI, mild cognitive impairment; MMSE, Mini‐Mental State Examination; MRI, magnetic resonance imaging; N/A, not applicable; NIA‐AA, National Institute on Aging‐Alzheimer's Association; PET, positron emission tomography; QTcF, QT interval corrected using Fridericia's formula; RBANS DMI, Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index.