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. 2018 Mar 8;4:150–160. doi: 10.1016/j.trci.2018.02.002

Table 1.

Inclusion and exclusion criteria

  • Inclusion criteria
    • •
      Membership in PSEN1 E280A mutation carrier kindred
    • •
      PSEN1 E280A mutation carrier or noncarrier status has been confirmed by separate laboratory
    • •
      Men and women, age ≥30 years and ≤60 years
    • •
      MMSE ≥ 26 (changed to MMSE of ≥24 for participants with <9 years of education, or MMSE of ≥26 for those with ≥9 years of education)
    • •
      Does not meet criteria for dementia due to AD [34]
    • •
      Does not meet criteria for MCI due to AD [33] as defined by cutoff scores on the Subjective Memory Checklist, CERAD Word List Recall, and FAST
    • •
      If female, and not documented to be surgically sterile, willing to undergo pregnancy tests per protocol
    • •
      For women who are not surgically sterile, agreement to remain abstinent or use two methods of contraception
    • •
      For men with partners of childbearing potential, agreement to remain abstinent or use a condom
    • •
      Study partner who agrees to participate in the study and is capable of and willing to accompany the participant to all visits
    • •
      Serum TSH and B12 within normal range (changed to also allow values out of range if judged not to be clinically significant)
  • Exclusion criteria
    • •
      Has significant medical, psychiatric, or neurological condition or disorder
    • •
      History of stroke
    • •
      Body weight <40 or >120 kg (lower limit changed to 45 kg)
    • •
      Clinically significant depression
    • •
      History of seizures (excluding febrile seizures of childhood or other isolated seizure episodes that were not due to epilepsy)
    • •
      Brain MRI results at baseline showing
      • ○
        evidence of amyloid-related imaging abnormality–edema, infection, significant cerebral vascular pathology, clinically significant lacunar infarct, multiple lacunes, cortical infarct, or focal lesions
      • ○
        more than four cerebral microhemorrhages
      • ○
        single area of superficial siderosis or prior cerebral macrohemorrhage
    • •
      Clinically significant screening blood laboratory abnormalities
    • •
      Positive urine test for drugs of abuse at screening (changed to allow for one additional screening; a second positive test [except for cannabinoids] would result in exclusion)
    • •
      Use of any other medications with the potential to significantly affect cognition

Abbreviations: AD, Alzheimer's disease; FAST, Functional Assessment Staging Test; MCI, mild cognitive impairment; MRI, magnetic resonance imaging; PSEN1, presenilin 1; RNA, ribonucleic acid; MMSE, Mini–Mental Status Examination; TSH, thyroid-stimulating hormone.

NOTE. Bolded font criteria represent key amendments.