Ruth Remington

Efficacy of a Vitamin/Nutriceutical Formulation for Moderate-stage to Later-stage Alzheimer's disease: A Placebo-controlled Pilot Study

Recent studies demonstrated efficacy of a vitamin/ nutriceutical formulation (folate, vitamin B12, alpha-tocopherol, S-adenosyl methionine, N-acetyl cysteine, and acetyl-L-carnitine) for mild to moderate Alzheimers disease. Herein, we tested the efficacy of this formulation in a small cohort of 12 institutionalized patients diagnosed with moderate-stage to later-stage Alzheimers disease. Participants were randomly separated into treatment of placebo groups. Participants receiving the formulation demonstrated a clinically significant delay in decline in the Dementia Rating Scale and clock-drawing test as compared to those receiving placebo. Institutional caregivers reported approximately 30% improvement in the Neuropyschiatric Inventory and maintenance of performance in the Alzheimers Disease Cooperative Study—Activities of Daily Living for more than 9 months. This formulation holds promise for delaying the decline in cognition, mood, and daily function that accompanies the progression of Alzheimers disease, and may be particularly useful as a supplement for pharmacological approaches during later stages of this disorder. A larger trial is warranted.

Efficacy of a Vitamin/Nutriceutical Formulation for Early-stage Alzheimer's Disease: A 1-year, Open-label Pilot Study With an 16-Month Caregiver Extension

We examined the efficacy of a vitamin/nutriceutical formulation (folate, vitamin B6, alpha-tocopherol, S-adenosyl methionine, N-acetyl cysteine, and acetyl-L-carnitine) in a 12-month, open-label trial with 14 community-dwelling individuals with early-stage Alzheimers disease. Participants improved in the Dementia Rating Scale and Clock-drawing tests (Clox 1 and 2). Family caregivers reported improvement in multiple domains of the Neuropsychiatric Inventory (NPI) and maintenance of performance in the Alzheimers Disease Cooperative Study—Activities of Daily Living (ADL). Sustained performance was reported by caregivers for those participants who continued in an 16-month extension. Performance on the NPI was equivalent to published findings at 3 to 6 months for donepezil and exceeded that of galantamine and their historical placebos. Participants demonstrated superior performance for more than 12 months in NPI and ADL versus those receiving naproxen and rofecoxib or their placebo group. This formulation holds promise for treatment of early-stage Alzheimers disease prior to and/or as a supplement for pharmacological approaches. A larger, placebo-controlled trial is warranted.

Hypodermoclysis to Treat Dehydration: A Review of the Evidence

Dehydration is a serious acute condition in older adults associated with significant morbidity and mortality. Hypodermoclysis (HDC; the infusion of fluids into the subcutaneous tissue) can provide an alternative to intravenous (IV) rehydration of older adults.

Effects of Calming Music on the Level of Agitation in Cognitively Impaired Nursing Home Residents

This study examines the use of music as a strategy to decrease agitated behavior in cognitively impaired nursing home residents. Twenty agitated subjects, 68 to 84 years of age, were exposed to 15 minutes of calming music on two occasions. Agitated behavior scores were recorded before, during and after the musical intervention using the Agitated Behavior Scale. Results indicate that a statistically significant reduction in agitated behavior occurs both during (p. <0]) and after the musical intervention (p. <05). Calming music was shown to be an effective, nonpharmacologic strategy which nurses and other caregivers may use to reduce agitated behavior in the nursing home.

A Phase II Randomized Clinical Trial of a Nutritional Formulation for Cognition and Mood in Alzheimer's Disease.

BACKGROUND Increasing evidence points toward the efficacy of nutritional modifications in delaying cognitive decline and mood/behavioral difficulties in Alzheimers disease (AD). Nutritional supplementation with individual agents has shown varied results suggesting the need for combinatorial intervention. OBJECTIVE We set out to determine whether nutritional intervention could positively impact cognitive performance and behavioral difficulties for individuals diagnosed with AD. METHODS A double-blind, multi-site, phase II study (ClinicalTrials.gov NCT01320527; Alzheimers Association Trialmatch) was conducted in which 106 individuals with AD were randomized to a nutraceutical formulation (NF; folate, alpha-tocopherol, B12, S-adenosyl methioinine, N-acetyl cysteine, acetyl-L-carnitine) or placebo for 3 or 6 months, followed by an open-label extension where participants received NF for 6 additional months. RESULTS The NF cohort improved versus the placebo cohort within 3 months (Clox-1 p = 0.0083, 95%CI [0.4481, 2.9343]; Dementia Rating Scale p = 0.0266, 95%CI [0.1722, 2.7171]). Caregivers reported non-significant improvements in Neuropsychiatric Inventory. Both cohorts improved or maintained baseline performance during open-label extensions. Activities of Daily Living did not change for either cohort. CONCLUSIONS These findings extend phase I studies where NF maintained or improved cognitive performance and mood/behavior.

Nutrition and Dementia: Are we Asking the Right Questions?

Alzheimers disease (AD) has no cure or nullifying pharmacological interventions. Nutritional supplementation represents a systemic approach that in some studies has provided benefit and has augmented pharmacological approaches. However, additional studies report no benefit of supplementation. We review herein how studies of nutrition on dementia, including those combining nutrition and dementia, are inherently compromised. We also review studies with mice, which demonstrate that nutritional supplementation can alleviate multiple genetic risk factors for AD. An individual diagnosed with AD has by definition undergone considerable cognitive decline; anticipating restoration/maintenance of cognitive performance following nutritional supplementation alone may be misdirected. Nutrition declines in aging, and even more so in AD. While optimization of nutrition should ideally be initiated well before any cognitive decline, we present evidence that the systemic benefit alone of nutritional supplementation at the very minimum warrants initiation along with pharmacological intervention.

Apple Juice Improved Behavioral But Not Cognitive Symptoms in Moderate-to-Late Stage Alzheimer’s Disease in an Open-Label Pilot Study:

Preclinical studies demonstrate that apple juice exerts multiple beneficial effects including reduction of central nervous system oxidative damage, suppression of Alzheimer’s disease (AD) hallmarks, improved cognitive performance, and organized synaptic signaling. Herein, we initiated an open-label clinical trial in which 21 institutionalized individuals with moderate-to-severe AD consumed 2 4-oz glasses of apple juice daily for 1 month. Participants demonstrated no change in the Dementia Rating Scale, and institutional caregivers reported no change in Alzheimer’s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL) in this brief study. However, caregivers reported an approximate 27% (P < .01) improvement in behavioral and psychotic symptoms associated with dementia as quantified by the Neuropsychiatric Inventory, with the largest changes in anxiety, agitation, and delusion. This pilot study suggests that apple juice may be a useful supplement, perhaps to augment pharmacological approaches, for attenuating the decline in mood that accompanies progression of AD, which may also reduce caregiver burden.

Nutritional supplementation for Alzheimer's disease?

Purpose of review Evidence for the benefit of nutrition in Alzheimers disease continues to accumulate. Many studies with individual vitamins or supplements show marginal, if any, benefit. However, new findings with combinatorial formulations demonstrate improvement in cognitive performance and behavioral difficulties that accompany Alzheimers disease. Herein, we review some of the most recent clinical advances and summarize supportive preclinical studies. Recent findings We present novel positive effects on Alzheimers disease derived from diet, trace elements, vitamins and supplements. We discuss the inherent difficulty in conducting nutritional studies because of the variance in participants’ nutritional history, versus pharmacological interventions in which participants are naive to the intervention. We examine the evidence that epigenetics play a role in Alzheimers disease and how nutritional intervention can modify the key epigenetic events to maintain or improve cognitive performance. Summary Overall consideration of the most recent collective evidence suggests that the optimal approach for Alzheimers disease would seem to combine early, multicomponent nutritional approaches (a Mediterranean-style diet, multivitamins and key combinatorial supplements), along with lifestyle modifications such as social activity and mental and physical exercise, with ultimate addition of pharmacological agents when warranted.

Dehydration Reduction in the Community Dwelling Older Adult: Perspectives of Community Health Care Providers

Dehydration is a common problem among older adults and can negatively affect their health. This cross-sectional descriptive study used survey findings and focus group interviews to investigate dehydration problems among community-dwelling older adults and to identify strategies perceived to be helpful in preventing dehydration in this population. The survey sample (n = 18) and four focus groups (n = 36) included health care providers in the northeast United States from provider agencies representing emergency care, home care, primary care, and community health care. Survey findings indicated that 89% of participants identify dehydration as a problem affecting older adults, and 94% noted the need for a public campaign on dehydration awareness and reduction. Four major themes emerged: Intentional Avoidance and Caution, Lack of Awareness/Education/Understanding, Poor Access to Fluids, and Social and Environmental Influences. Strategies identified to promote hydration in community-dwelling older adults included community partnerships, community education, community engagement, and interdisciplinary approaches. This study provides useful information and detailed strategies recommended by health care providers for designing interventions to promote hydration for community-dwelling older adults.

Maintenance of Cognitive Performance and Mood for Individuals with Alzheimer’s Disease Following Consumption of a Nutraceutical Formulation: A One-Year, Open-Label Study

Nutritional interventions have shown varied efficacy on cognitive performance during Alzheimers disease (AD). Twenty-four individuals diagnosed with AD received a nutraceutical formulation (NF: folate, alpha-tocopherol, B12, S-adenosyl methioinine, N-acetyl cysteine, acetyl-L-carnitine) under open-label conditions (ClinicalTrials.gov NCT01320527). Primary outcome was cognitive performance. Secondary outcomes were behavioral and psychological symptoms of dementia (BPSD) and activities of daily living. Participants maintained their baseline cognitive performance and BPSD over 12 months. These findings are consistent with improvement in cognitive performance and BPSD in prior placebo-controlled studies with NF, and contrast with the routine decline for participants receiving placebo.