The Alzheimer's Disease Assessment Scale: Evaluation of Psychometric Properties and Patterns of Cognitive Decline in Multicenter Clinical Trials of Mild to Moderate Alzheimer's Disease

Doraiswamy, P. Murali; Kaiser, Lee; Bieber, Florian; Garman, Robert H.

doi:10.1097/00002093-200110000-00003

Cited by 95 publications

(81 citation statements)

References 19 publications

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“…19,35 The ADAS-Cog is most sensitive to change in patients with moderate disease. 36,37 Since the NTB captures changes in delayed memory and executive function which are not well-covered by the ADAS-Cog, our findings support the choice of the NTB for studies in mild AD.…”

Section: Discussionsupporting

confidence: 59%

A phase 2 randomized trial of ELND005, scyllo-inositol, in mild to moderate Alzheimer disease

Salloway¹,

Sperling²,

Keren³

et al. 2011

Neurology

236

161

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Objective: This randomized, double-blind, placebo-controlled, dose-ranging phase 2 study explored safety, efficacy, and biomarker effects of ELND005 (an oral amyloid anti-aggregation agent) in mild to moderate Alzheimer disease (AD). Methods:A total of 353 patients were randomized to ELND005 (250, 1,000, or 2,000 mg) or placebo twice daily for 78 weeks. Coprimary endpoints were the Neuropsychological Test Battery (NTB) and Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale. The primary analysis compared 250 mg (n ϭ 84) to placebo (n ϭ 82) after an imbalance of infections and deaths led to early discontinuation of the 2 higher dose groups. Results:The 250 mg dose demonstrated acceptable safety. The primary efficacy analysis at 78 weeks revealed no significant differences between the treatment groups on the NTB or ADCS-ADL. Brain ventricular volume showed a small but significant increase in the overall 250 mg group (p ϭ 0.049). At the 250 mg dose, scyllo-inositol concentrations increased in CSF and brain and CSF A␤x-42 was decreased significantly compared to placebo (p ϭ 0.009). Conclusions:Primary clinical efficacy outcomes were not significant. The safety and CSF biomarker results will guide selection of the optimal dose for future studies, which will target earlier stages of AD.

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Section: Discussionsupporting

confidence: 59%

A phase 2 randomized trial of ELND005, scyllo-inositol, in mild to moderate Alzheimer disease

Salloway¹,

Sperling²,

Keren³

et al. 2011

Neurology

236

161

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“…11 In clinical trials, a change of 4 points is considered clinically significant for patients with mild to moderate dementia. 39,40 As such, the symptomatic improvements observed are modest and of debatable clinical significance, despite being statistically significant. 35 In a meta-analysis of 16 double-blind, placebo-controlled trials of ChEIs composed of almost 8000 patients, the numbers needed to treat for one additional patient to benefit were 7 for stabilization or better, 12 for minimal improvement or better, and 42 for marked improvement.…”

Section: Mild To Moderate Diseasementioning

confidence: 99%

Guidelines for the Management of Cognitive and Behavioral Problems in Dementia

Sadowsky¹,

Galvin²

2012

The Journal of the American Board of Family Medicine

117

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Family physicians play a crucial role in the management and ongoing care of patients with Alzheimer disease (AD). This article reviews the effects of nonpharmacologic and pharmacologic interventions on the functional abilities and behavior of patients with dementia and how these can be implemented into clinical practice. Nonpharmacologic interventions are recommended as the initial strategy for managing problematic behaviors. Strategies for improving behavior include ensuring that the patient's environment is safe, calm, and predictable; removing environmental stressors; and identifying and avoiding situations that agitate or frighten the patient. Simple interventions include redirecting and refocusing the patient, increasing social interaction, establishing regular sleep habits, eliminating sources of conflict and frustration, and establishing rewards for successes. The effectiveness of long-term behavioral management is largely dependent on the caregiver; as such, it is important to assess the role and needs of the caregiver.Because currently available therapies cannot reverse the pathologic processes of AD, the primary objective of pharmacotherapy is to preserve cognitive and functional ability, minimize behavioral disturbances, and slow disease progression. Cholinesterase inhibitors represent first-line therapy for patients with mild to moderate AD, whereas a glutamate N-methyl D-aspartate antagonist is used in the treatment of moderate to severe AD. Looking forward, there are a number of therapies in development aimed at modifying the disease course; these include amyloid-lowering drugs, -based and neuroprotective approaches, acetylcholine agonists, and mitochondrial inhibitors.

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“…A change of 4 points is considered clinically significant for patients with mild to moderate dementia. 20,29 After 6 months of therapy, patients who received a cholinesterase inhibitor had a score that was on average 2.7 points better (95% confidence interval [CI] 2.3-3.0) than the score for participants in the placebo group. 19 Among patients with mild to moderate Alzheimer disease, about 15% more patients receiving a cholinesterase inhibitor than of those receiving a placebo had the same or an improved score on a global assessment scale.…”

Section: Effectivenessmentioning

confidence: 99%

Diagnosis and treatment of dementia: 5. Nonpharmacologic and pharmacologic therapy for mild to moderate dementia

Hogan¹,

Bailey²,

Black³

et al. 2008

Canadian Medical Association Journal

133

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The Alzheimer's Disease Assessment Scale: Evaluation of Psychometric Properties and Patterns of Cognitive Decline in Multicenter Clinical Trials of Mild to Moderate Alzheimer's Disease

Cited by 95 publications

References 19 publications

A phase 2 randomized trial of ELND005, scyllo-inositol, in mild to moderate Alzheimer disease

A phase 2 randomized trial of ELND005, scyllo-inositol, in mild to moderate Alzheimer disease

Guidelines for the Management of Cognitive and Behavioral Problems in Dementia

Diagnosis and treatment of dementia: 5. Nonpharmacologic and pharmacologic therapy for mild to moderate dementia

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