An Inventory to Assess Activities of Daily Living for Clinical Trials in Alzheimerʼs Disease

Galasko, Douglas; Bennett, David A.; Sano, Mary; Ernesto, Christopher; Thomas, Ronald J.; Grundman, Michael; Ferris, Steven H.

doi:10.1097/00002093-199700112-00005

Cited by 1,042 publications

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“…The neuropsychological test battery included several domains of cognitive function. The Mini-Mental State Examination (Folstein, Folstein & McHugh, 1975) and Activities of Daily Living scale (Galasko et al, 1997) were used to screen for dementia. Episodic memory was assessed with the WMS-III Logical Memory subtest and CERAD Word List Learning Task (Morris et al, 1989).…”

Section: Subjectsmentioning

confidence: 99%

Memory Evaluation in Mild Cognitive Impairment using Recall and Recognition Tests

Bennett

Golob

Parker

et al. 2006

Journal of Clinical and Experimental Neuropsychology

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Section: Subjectsmentioning

confidence: 99%

Memory Evaluation in Mild Cognitive Impairment using Recall and Recognition Tests

Bennett

Golob

Parker

et al. 2006

Journal of Clinical and Experimental Neuropsychology

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“…In addition to its extensive use and applicability, the ADAS-cog is more sensitive to a wide range of disease severity and has specificity to major AD-related dysfunctions. Activities of daily living (ADL) were assessed using two instruments developed specifically for patients with AD: the Disability Assessment for Dementia (DAD) scale (19) and the Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) inventory (18). Both instruments assess items related to both basic self-care and instrumental ADL.…”

Section: Outcome Measuresmentioning

confidence: 99%

Galantamine — a Novel Cholinergic Drug with a Unique Dual Mode of Action for the Treatment of Patients with Alzheimer's Disease

2002

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Galantamine hydrobromide is a tertiary alkaloid drug that has been developed and approved in a number of countries including the USA and several countries in Europe as a treatment for mild-to-moderate Alzheimer's disease (AD). Galantamine has a unique, dual mode of action. It is a reversible, competitive inhibitor of acetylcholinesterase (AChE), and is the only drug actively marketed for the treatment of AD with proven activity as an allosteric modulator of nicotinic acetylcholine receptors (nAChRs). This latter activity is thought to be particularly important since decreases in the expression and activity of nAChRs make a large contribution to the reduction in central cholinergic neurotransmission in patients with AD. Galantamine exhibits favorable pharmacokinetic characteristics including predictable linear elimination kinetics at the recommended maintenance doses (16 and 24 mg/day), a relatively short half-life (approximately 7 h) and high bioavailability. It is extensively metabolized in numerous pathways, mainly in the liver via cytochrome P450 enzymes CYP2D6 and CYP3A4, and has a low potential for clinically significant drug-drug interactions. During four large randomized, double-blind, placebocontrolled trials of up to 6 months duration, galantamine 16 and 24 mg/day significantly benefited cognitive and global function, ability to perform activities of daily living (ADL) and behavior, relative to placebo and baseline, for up to 6 months. Caregiver burden (time spent by caregivers supervising patients or assisting them with ADL), and caregiver distress (related to patients' behavioral symptoms) were also reduced. Cognitive and functional abilities were preserved at or near baseline for at least 12 months in patients who re- 159CNS Drug Reviews Vol. 8, No.2, pp. 159-176 © 2002 Neva Press, Branford, Connecticut Address correspondence and reprint requests to: Sean Lilienfeld, MBBCh, FCP(SA), MMed(Neuro), Janssen Pharmaceutica Inc, Janssen Research Foundation, Div of Janssen Pharmaceutica Ltd, 1125 Trenton Harbourton Road, Titusville NJ 08560. Tel.: +1 (609) 730-3414; Fax: +1 (609) 730-2441; E-mail: slilien1@janus.jnj.com ceived galantamine 24 mg/day for 12 months in a long-term US study. These benefits were maximized by early and continued galantamine treatment and, again, were associated with significant reductions in caregiver burden. Trials of the efficacy of galantamine in dementia related to cerebrovascular disease have also yielded positive results. There are no safety concerns associated with the use of galantamine. The incidence of adverse events, particularly cholinergically mediated events affecting the gastrointestinal system, is generally low and can be minimized using the recommended slow dose-escalation scheme. Galantamine may, therefore, help to reduce the overall burden and cost involved in caring for dementia patients. Taking all evidence into account, galantamine has the potential to become a first-line therapy for dementia.

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“…Biomarker outcomes included MRI measurement of change in ventricular volume, hippocampal volume, and total brain volume from baseline to 18 months, and change in serum immunoglobulin, plasma Ab-40 and Ab-42 levels, and anti-Ab antibodies from baseline to 18 months. Substudies assessed change in cerebral Ab burden by 18 F-florbetapir PET and CSF analysis of tau, phosphotau, Ab-42, and anti-Ab levels.…”

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confidence: 99%

A phase 3 trial of IV immunoglobulin for Alzheimer disease

et al. 2017

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Objective: We tested biweekly infusions of IV immunoglobulin (IVIg) as a possible treatment for mild to moderate Alzheimer disease (AD) dementia.Methods: In a phase 3, double-blind, placebo-controlled trial, we randomly assigned 390 participants with mild to moderate AD to receive placebo (low-dose albumin) or IVIg (Gammagard Liquid; Baxalta, Bannockburn, IL) administered IV at doses of 0.2 or 0.4 g/kg every 2 weeks for 18 months. The primary cognitive outcome was change from baseline to 18 months on the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale; the primary functional outcome was 18-month change on the Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory. Safety and tolerability data, as well as serial MRIs and plasma samples, were collected throughout the study from all enrolled participants. Results:No beneficial effects were observed in the dual primary outcome measures for the 2 IVIg doses tested. Significant decreases in plasma Ab42 (but not Ab40) levels were observed in IVIgtreated participants. Analysis of safety data showed no difference between IVIg and placebo in terms of the rate of occurrence of amyloid-related imaging abnormalities (brain edema or microhemorrhage). IVIg-treated participants had more systemic reactions (chills, rashes) but fewer respiratory infections than participants receiving placebo.Conclusions: Participants with mild to moderate AD showed good tolerability of treatment with low-dose human IVIg for 18 months but did not show beneficial effects on cognition or function relative to participants who received placebo.Clinicaltrials.gov identifier: NCT00818662.

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An Inventory to Assess Activities of Daily Living for Clinical Trials in Alzheimerʼs Disease

Cited by 1,042 publications

References 0 publications

Memory Evaluation in Mild Cognitive Impairment using Recall and Recognition Tests

Memory Evaluation in Mild Cognitive Impairment using Recall and Recognition Tests

Galantamine — a Novel Cholinergic Drug with a Unique Dual Mode of Action for the Treatment of Patients with Alzheimer's Disease

A phase 3 trial of IV immunoglobulin for Alzheimer disease

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