Baseline demographic, clinical, and cognitive characteristics of the Alzheimer's Prevention Initiative (API) Autosomal‐Dominant Alzheimer's Disease Colombia Trial

Abstract

Introduction The API AutosomalDominant AD (ADAD) Colombia Trial is a placebo‐controlled clinical trial of crenezumab in 252 cognitively unimpaired 30 to 60‐year‐old Presenilin 1 (PSEN1) E280A kindred members, including mutation carriers randomized to active treatment or placebo and non‐carriers who receive placebo. Methods Of the 252 enrolled, we present data on a total of 242 mutation carriers and non‐carriers matched by age range, excluding data on 10 participants to protect participant confidentiality, genetic status, and trial integrity. Results We summarize demographic, clinical, cognitive, and behavioral data from 167 mutation carriers and 75 non‐carriers, 30 to 53 years of age. Carriers were significantly younger than non‐carriers ((mean age ± SD) 37 ± 5 vs 42 ± 6), had significantly lower Mini Mental Status Exam (MMSE) scores (28.8 ± 1.4 vs 29.2 ± 1.0), and had consistently lower memory scores. Discussion Although PSEN1 E280A mutation carriers in the Trial are cognitively unimpaired, they have slightly lower MMSE and memory scores than non‐carriers. Their demographic characteristics are representative of the local population.

Sex differences in cognitive resilience in preclinical autosomal‐dominant Alzheimer's disease carriers and non‐carriers: Baseline findings from the API ADAD Colombia Trial

“…As previously reported, 24 baseline characteristics of PSEN1 carriers and non-carriers are described in Table S1 in the Supporting Information. Demographic, clinical, cognitive, and neuroimaging data among male and female PSEN1 mutation carriers and non-carriers are described in detail in Table 1.…”

“…A total of 167 PSEN1 mutation carriers (ages: 30 to 53, mean age: 37 ± 5 years; 60% women) and 75 age-matched non-carriers (ages: 30 to 53, mean age: 42 ± 6 years; 67% women) from the API Autosomal Dominant AD Colombia Trial were included in the study. 24 Potentially eligible trial candidates from the Colombian API Registry 25 were pre-screened following procedures and included in the study following inclusion and exclusion criteria described in detail elsewhere. 23 In brief, the inclusion criteria were ( 26 > 26 for participants with > 9 years of education and MMSE > 24 for participants with < 9 years of education; and (4) not meeting criteria for MCI or dementia due to AD 27,28 based on performance on clinical and cognitive measures.…”

Alzheimer disease

“…Several other therapies are in various stages of clinical development such as drugs directed against tau accumulation or spread in later phase development 266 . Two secondary prevention studies for AD are ongoing, both with passive Aβ immunization; neither the API study 267 nor the A4 study 268 will report results until at least 2022.…”

PET evidence of preclinical cerebellar amyloid plaque deposition in autosomal dominant Alzheimer’s disease-causing Presenilin-1 E280A mutation carriers

“…Cognitive assessments were done within 1–3 months of the brain scans for the API ADAD cohort and two months for the COLBOS cohort ( Quiroz et al, 2018 ). Details of baseline demographic, clinical, and cognitive characteristics for the API ADAD Colombia Trial are described in Rios‐Romenets et al (2020) . Studies were approved by the University of Antioquia Ethics Committee in accordance with international ethics committee standards.…”