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Gait speed, cognition and falls in people living with mild-to-moderate Alzheimer disease: data from NILVAD.

ABSTRACT: BACKGROUND:Previous evidence suggests that slower gait speed is longitudinally associated with cognitive impairment, dementia and falls in older adults. Despite this, the longitudinal relationship between gait speed, cognition and falls in those with a diagnosis of dementia remains poorly explored. We sought to assess this longitudinal relationship in a cohort of older adults with mild to-moderate Alzheimer Disease (AD). METHODS:Analysis of data from NILVAD, an 18-month randomised-controlled trial of Nilvadipine in mild to moderate AD. We examined: (i) the cross-sectional (baseline) association between slow gait speed and cognitive function, (ii) the relationship between baseline slow gait speed and cognitive function at 18?months (Alzheimer Disease Assessment Scale, Cognitive Subsection: ADAS-Cog), (iii) the relationship between baseline cognitive function and incident slow gait speed at 18?months and finally (iv) the relationship of baseline slow gait speed and incident falls over the study period. RESULTS:Overall, one-tenth (10.03%, N?=?37/369) of participants with mild-to-moderate AD met criteria for slow gait speed at baseline and a further 14.09% (N?=?52/369) developed incident slow gait speed at 18?months. At baseline, there was a significant association between poorer cognition and slow gait speed (OR 1.05, 95% CI 1.01-1.09, p?=?0.025). Whilst there was no association between baseline slow gait speed and change in ADAS-Cog score at 18?months, a greater cognitive severity at baseline predicted incident slow gait speed over 18?months (OR 1.04, 1.01-1.08, p?=?0.011). Further, slow gait speed at baseline was associated with a significant risk of incident falls over the study period, which persisted after covariate adjustment (IRR 3.48, 2.05-5.92, p?

SUBMITTER: Dyer AH

PROVIDER: S-EPMC7106668 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Gait speed, cognition and falls in people living with mild-to-moderate Alzheimer disease: data from NILVAD.

Dyer Adam H AH Lawlor Brian B Kennelly Sean P SP

BMC geriatrics 20200330 1

<h4>Background</h4>Previous evidence suggests that slower gait speed is longitudinally associated with cognitive impairment, dementia and falls in older adults. Despite this, the longitudinal relationship between gait speed, cognition and falls in those with a diagnosis of dementia remains poorly explored. We sought to assess this longitudinal relationship in a cohort of older adults with mild to-moderate Alzheimer Disease (AD).<h4>Methods</h4>Analysis of data from NILVAD, an 18-month randomised ...[more]

PMID: 32228468

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Project description:ObjectivesRecent research has indicated seemingly increased propensity for falls and accelerated bone demineralisation in people living with HIV (PLWH). We aim to map out the extent and nature of existing research relating to falls in PLWH and describe the relationship between bone demineralisation and falls in PLWH.MethodsA scoping review was done following Arksey & O'Malley's methodological framework and recommendations from Joanna Briggs Institute. Four databases were searched until October 2019 for peer-reviewed studies available in English reporting on the definition, prevalence, assessment, risk factors and interventions for falls in PLWH as well as information on bone demineralisation linked to falls in PLWH. Narrative reviews were excluded. Two reviewers independently performed the extraction using a predesigned Excel sheet. A descriptive analysis of extracted information was done.ResultsFourteen studies on falls in older PLWH were identified, with all but one study conducted in high-income countries. Prevalence of falls in PLWH ranged from 12% to 41%. Variable assessment tools/tests were used to assess potential risk factors, but it remains to be determined which are more predictive and appropriate for use among PLWH. Considerable agreement existed for risk factors regarding use of medications while evidence regarding functional and cognitive impairments were variable. Few studies compared risk factors for falls in PLWH with those in age-matched and sex-matched seronegative population. There is currently no evidence for interventions to prevent or reduce falls risk in PLWH.ConclusionMore research is needed on falls in younger cohorts of PLWH and in sub-Saharan Africa where HIV is most prevalent and more robust clades exist. More studies need to report on data in seronegative controls to determine risk factors unique to PLWH. More intervention studies targeted at falls prevention and promotion of bone health are required. Quality clinical practice guidelines highlighting validated assessment tools and outcome measures need to be developed.

Project description:BACKGROUND:This study reports the findings of the first large-scale Phase III investigator-driven clinical trial to slow the rate of cognitive decline in Alzheimer disease with a dihydropyridine (DHP) calcium channel blocker, nilvadipine. Nilvadipine, licensed to treat hypertension, reduces amyloid production, increases regional cerebral blood flow, and has demonstrated anti-inflammatory and anti-tau activity in preclinical studies, properties that could have disease-modifying effects for Alzheimer disease. We aimed to determine if nilvadipine was effective in slowing cognitive decline in subjects with mild to moderate Alzheimer disease. METHODS AND FINDINGS:NILVAD was an 18-month, randomised, placebo-controlled, double-blind trial that randomised participants between 15 May 2013 and 13 April 2015. The study was conducted at 23 academic centres in nine European countries. Of 577 participants screened, 511 were eligible and were randomised (258 to placebo, 253 to nilvadipine). Participants took a trial treatment capsule once a day after breakfast for 78 weeks. Participants were aged >50 years, meeting National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's disease Criteria (NINCDS-ADRDA) for diagnosis of probable Alzheimer disease, with a Standardised Mini-Mental State Examination (SMMSE) score of ?12 and <27. Participants were randomly assigned to 8 mg sustained-release nilvadipine or matched placebo. The a priori defined primary outcome was progression on the Alzheimer's Disease Assessment Scale Cognitive Subscale-12 (ADAS-Cog 12) in the modified intention-to-treat (mITT) population (n = 498), with the Clinical Dementia Rating Scale sum of boxes (CDR-sb) as a gated co-primary outcome, eligible to be promoted to primary end point conditional on a significant effect on the ADAS-Cog 12. The analysis set had a mean age of 73 years and was 62% female. Baseline demographic and Alzheimer disease-specific characteristics were similar between treatment groups, with reported mean of 1.7 years since diagnosis and mean SMMSE of 20.4. The prespecified primary analyses failed to show any treatment benefit for nilvadipine on the co-primary outcome (p = 0.465). Decline from baseline in ADAS-Cog 12 on placebo was 0.79 (95% CI, -0.07-1.64) at 13 weeks, 6.41 (5.33-7.49) at 52 weeks, and 9.63 (8.33-10.93) at 78 weeks and on nilvadipine was 0.88 (0.02-1.74) at 13 weeks, 5.75 (4.66-6.85) at 52 weeks, and 9.41 (8.09-10.73) at 78 weeks. Exploratory analyses of the planned secondary outcomes showed no substantial effects, including on the CDR-sb or the Disability Assessment for Dementia. Nilvadipine appeared to be safe and well tolerated. Mortality was similar between groups (3 on nilvadipine, 4 on placebo); higher counts of adverse events (AEs) on nilvadipine (1,129 versus 1,030), and serious adverse events (SAEs; 146 versus 101), were observed. There were 14 withdrawals because of AEs. Major limitations of this study were that subjects had established dementia and the likelihood that non-Alzheimer subjects were included because of the lack of biomarker confirmation of the presence of brain amyloid. CONCLUSIONS:The results do not suggest benefit of nilvadipine as a treatment in a population spanning mild to moderate Alzheimer disease. TRIAL REGISTRATION:Clinicaltrials.gov NCT02017340, EudraCT number 2012-002764-27.

Dataset Information

Gait speed, cognition and falls in people living with mild-to-moderate Alzheimer disease: data from NILVAD.

Publications

Gait speed, cognition and falls in people living with mild-to-moderate Alzheimer disease: data from NILVAD.

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