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. 2023 Jan 20;21(1):e07704. doi: 10.2903/j.efsa.2023.7704

Cohort name

Country

Reference

Follow‐up

Funding

Original Cohort (N total)

Exclusion criteria

Study population (n, sex and age at baseline(a))

Ascertainment of outcome

Exposure groups(a)

n

Incident cases Model covariates Results

PREADVISE

USA, Canada and Puerto Rico

Kryscio et al. (2017)

Approx. 5 yr RCT + 7 yr observational follow‐up

Public

N = 7,540

Population sampled: Subsample of participants from SELECT

Exclusion: dementia, active neurologic and/or neuropsychiatric conditions affecting cognition; history of serious head injury and substance abuse; no follow‐up visit

n = 3,786

Sex: Males

Ethnicity: 8.4% Black, 2.5% Hispanic, 89.1% White

Age: > 60 yr

Incidence of dementia; Memory Impairment Screening (MIS) test at follow‐up visit; cases identified based on MIS test and i) followed by diagnostic by local clinician, or ii) AD8 Dementia Screening Interview ≥ 1 plus a self‐reported dementia diagnosis, use of a memory enhancing prescription drug, or cognitive score ≥ 1.5 SDs below expected performance

n, per group

G1, placebo*: 1,830

G2, 200 μg Se/d*: 1,881

*5.4 ± 1.2 yr of intervention

Incident cases of dementia, n

G1: 85

G2: 78

Baseline age, black race, APOE ε4 carrier status (present or absent), college education, baseline MIS score, and the presence/absence of the following self‐reported co‐morbidities at PREADVISE baseline: coronary artery bypass graft (CABG), congestive heart failure (CHF), diabetes, hypertension, stroke, sleep apnoea, and memory change or problem

HR (95% CI) for incidence of dementia

G1: ref.

G2: 0.92 (0.63, 1.34)

Modified intent‐to‐treat analysis

G1: ref.

G2: 0.83 (0.61, 1.13)

Weighted for treatment compliance

G1: ref.

G2: 0.80 (0.59, 1.09)

PREADVISE: Prevention of Alzheimer's Disease with Vitamin E and Selenium; RCT: randomised controlled trial; SELECT: Selenium and Vitamin E Cancer Prevention Trial; yr: year.

(a) Mean ± SD (range), unless specified otherwise.