U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER): Baseline Characteristics of a Trial Cohort Enriched for Risk of Cognitive Decline
Bibliographic record
Abstract
Abstract Background U.S. POINTER is a two‐year clinical trial to evaluate whether lifestyle interventions targeting multiple risk factors protect cognitive function in older adults at increased risk for cognitive decline. We describe the baseline characteristics of the U.S. POINTER clinical trial cohort overall, and before and after changes in risk factor enrichment inclusion criteria. Method U.S. POINTER is a Phase 3, multicenter, randomized 2‐year clinical trial of two lifestyle interventions varying in intensity and format, in older adults at increased risk for cognitive decline and dementia. The study closed enrollment with 2111 individuals at 5 sites (North Carolina, Northern California, Chicagoland, Houston, Rhode Island). Eligible participants were sedentary and consumed a suboptimum diet and met other risk enrichment criteria that included first degree family history of memory impairment, and suboptimum cardiovascular health status (meeting specific cut‐points of systolic blood pressure, LDL cholesterol or hemoglobin A1c). 20 months into enrollment, risk enrichment criteria were revised to account for two other factors: older age (70‐79 years), and African American/Black or Native American race or Hispanic/Latine ethnicity. Result Mean age at baseline is 68.2 years, 31% represent communities of color, 69% are women, and 30% are not college graduates. 58% reported maternal memory loss, mean systolic blood pressure = 131 mmHg, mean total cholesterol = 193 mg/dl, mean HbA1C = 5.9%, and mean body mass index (BMI) = 29.9 kg/m2. Mean adjusted modified Telephone Interview for Cognitive Status (TICSm) score is = 37.6 (max = 50 pts), Geriatric Depression Score (GDS) is = 1.8, and Short Physical Performance Battery Chair Stand Score (SPBC) is = 3.3. Some baseline characteristics (BMI, total cholesterol, SBBP chair stand) vary by clinical site. The change to risk score enrichment criteria (Table 1) increased representation of participants from communities of color and number of males in the study cohort. Conclusion U.S. POINTER successfully enrolled 2111 participants across 5 sites who are at high risk for cognitive decline and dementia, with appropriate representation by groups typically underrepresented in clinical trials, individuals aged 75 or older, and men, with the expansion of risk score enrichment criteria.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.009 | 0.008 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".