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Table 1 Current Aβ therapeutics with rationale for AD prevention clinical trials

From: The informed road map to prevention of Alzheimer Disease: A call to arms

Class Compound Current status Disease Stage Trial #/Names Sample size Trial Outcome measures Evidence from clinical studies
Immuno-therapy ABvac 40 (active vaccine)a Phase 2 Mild AD NCT03461276 120b Safety and immune response >90% immune response [44]
ACI-24 (active vaccine) Phase 2 Asymptomatic Down Syndrome NCT04373616
ACI-24-0701
72b Safety and MRI Initial formulation with suboptimal immune response
BAN2410 Phase 2/3 Asymptomatic with low or higher amyloid plaque load NCT01767311
AHEAD (A345)
856 Safety and Cognitive change Active, results not yet available
CAD106 Phase 3 Asymptomatic sporadic AD NCT02565511 480 Cognitive change Terminated, results not yet available
Crenezumab Phase 2 Asymptomatic DIAD NCT01998841 252 Cognitive change Low to High dose being tested in Colombian kindred (PSEN-1_E280A)
Gantenerumab Phase 2/3 Asymptomatic DIAD;
Mild AD
NCT01760005
NCT03443973
73
982
Biomarker, Cognitive, and Clinical change Tau and neurodegeneration biomarker improvements with lowered CSF tau, p-tau181, and NfL. No clinical benefit in DIAD at low dose. High dose continued testing in DIAN-TU OLE prevention trial
Solanezumab Phase 3 Asymptomatic DIAD completed
Asymptomatic sporadic AD
NCT01760005
NCT02008357
A4
71
1150b
Biomarker, Cognitive, and Clinical change No tau or neurodegeneration biomarker improvements or clinical benefit in DIAD on low dose; asymptomatic sporadic AD prevention trial (A4) ongoing with higher dose
UB-311 (active vaccine)a Phase 2 Mild AD NCT02551809 43 Safety and immune response >90% immune response with a good safety profile.
Small Moleculec PQ912 (Inhibitor of glutaminyl cyclase) Phase 2 Early AD NCT03919162 414b Safety, PK and clinical outcomes Good safety profile; trends for cognitive benefit [45].
BACEi
JNJ-54861911
MK-8931 (verubecestat)
E2609
(Elenbecestat)
CNP520
LY3314814
Lanabecestat
Phase 3 Asymptomatic/Early AD NCT02569398
NCT01953601
NCT03036280
NCT03131453
NCT02245737
557
1454
2212
1145
2218
Negative effects in cognition, decrease Aβ Clinical studies halted due to safety concerns with rapid mild negative effects in cognition which may be reversable.
  1. The table represents the recent approaches to Aβ therapeutics highlighting new mechanisms to be tested on prevention trials
  2. aPotential agents for primary prevention
  3. bPotential agents for primary/secondary prevention. Proposed potential as a prevention therapy is based on how likely the known mechanism of action aligns with the disease stage of Aβ-pathology (prevent Aβ aggregation or Aβ plaques removal), the known side effect profile (long term treatments likely required) and the available data on clinical efficacy
  4. cEstimated enrollment