The Clinical Efficacy and Safety of Galantamine in the Treatment of Alzheimer's Disease

CNS Spectrums ◽  
2004 ◽  
Vol 9 (5) ◽  
pp. 377-392 ◽  
Author(s):  
Alan N. Dengiz ◽  
Paul Kershaw
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Daily Living ◽  
Phase Iii ◽  
Current Therapy ◽  
Newly Diagnosed ◽  
Short Term ◽  
Phase Iii Trials ◽  
Dual Mechanism ◽  
Esterase Inhibitor

AbstractAlzheimer's disease is a progressive, neurodegenerative condition characterized by deficits in cognition, inability to perform activities of daily living, and alterations in behavior. Galantamine hydrobromide is the newest acetylcholin esterase inhibitor (AChEI) approved in the United State for the treatment of mild-to-moderate AD. The safety and efficacy of galantamine has been demonstrated in multiple randomized, Phase III trials of > 2,600 patients with mild-to-moderate AD. Studies have found that galantamine improved or maintained performance in all domains of AD (cognition, function, behavior, and caregiver burden in the short term and slowed the decline in performance or maintained baseline performance through 12 months. The dual mechanism of action may make galantamine a reasonable treatment option for both newly diagnosed patients and patients who have not benefitted from or have poorly tolerated current therapy.

scholarly journals Plasma Neurofilament Light and Future Declines in Cognition and Function in Alzheimer’s Disease in the FIT-AD Trial

2021 ◽  
pp. 1-11
Author(s):  
Danni Li ◽  
Lin Zhang ◽  
Nathaniel W. Nelson ◽  
Michelle M. Mielke ◽  
Fang Yu
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Daily Living ◽  
Short Term ◽  
Neurofilament Light Chain ◽  
Neurofilament Light ◽  
Linear Mixed Effects ◽  
Future Studies ◽  
Rate Of Decline ◽  
And Function

Background: Utilities of blood-based biomarkers in Alzheimer’s disease (AD) clinical trials remain unknown. Objective: To evaluate the ability of plasma neurofilament light chain (NfL) to predict future declines in cognition and activities of daily living (ADL) outcomes in 26 older adults with mild-to-moderate AD dementia from the FIT-AD Trial. Methods: Plasma NfL was measured at baseline and 3 and 6 months. Cognition and ADL were assessed using the AD Assessment Scale-Cognition (ADAS-Cog) and AD Uniform Dataset Instruments and Disability Assessment for Dementia (DAD), respectively, at baseline, 3, 6, 9, and 12 months. Linear mixed effects models were used to examine the associations between baseline or change in plasma NfL and changes in outcomes. Results: Higher baseline plasma NfL was associated with greater rate of decline in ADAS-Cog from baseline to 6 months (standardized estimate of 0.00462, p = 0.02853) and in ADL from baseline to 12 months (standardized estimate of –0.00284, p = 0.03338). Greater increase in plasma NfL in short term from baseline to 3 months was associated with greater rate of decline in memory and ADL from 3 to 6 months (standardized estimate of –0.04638 [0.003], p = 0.01635; standardized estimate of –0.03818, p = 0.0435) and greater rate of decline in ADL from 3 to 12 month (standardized estimate of –0.01492, p = 0.01082). Conclusion: This study demonstrated that plasma NfL might have the potential to predict cognitive and function decline up to 12 months. However, future studies with bigger sample sizes need to confirm the findings.

O1-06-02: Effect of bapineuzumab on CSF p-tau and t-tau in mild-to-moderate Alzheimer's disease: Results from two phase III trials in APOE-ε4 carriers and noncarriers

2013 ◽  
Vol 9 ◽  
pp. P138-P138 ◽  
Author(s):  
Johannes Streffer ◽  
Kaj Blennow ◽  
Stephen Salloway ◽  
Henrik Zetterberg ◽  
Yi-Zheng Xu ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Phase Iii ◽  
Two Phase ◽  
Apoe Ε4 ◽  
Phase Iii Trials ◽  
T Tau

THREE CARDINAL LESSONS FROM ADAPT – 10 YEARS ON

2014 ◽  
pp. 1-5
Author(s):  
J.C.S. Breitner ◽  
C.G. Lyketsos
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Trial Design ◽  
Naproxen Sodium ◽  
Prevention Trial ◽  
Phase Iii ◽  
Increased Risk ◽  
Phase Iii Trials ◽  
Inflammatory Drugs ◽  
Anti Inflammatory

The Alzheimer’s Disease Anti-inflammatory Prevention Trial was a placebo-controlled three-arm pharmaco-prevention trial of the non-steroidal anti-inflammatory drugs naproxen sodium and celecoxib for prevention of incident Alzheimer’s disease (AD) dementia in older (aged 70 and over) adults. Although subjects were at increased risk of symptoms because of a firstdegree family history, they were meant to be cognitively healthy at enrollment. ADAPT encountered several problems that resulted in the termination of its treatments after only two years on average. Interim results were complex but potentially interesting. In the end, however, the results were null. We describe the complications that prevented ADAPT from achieving conclusive results, and suggest that these could have been avoided if the trial design and execution had been better guided by preliminary data. We believe such data should be available before beginning further ambitious phase III trials of this sort, and we suggest a broad method by which such data can be accumulated with reasonable economy.

scholarly journals Tau-Centric Targets and Drugs in Clinical Development for the Treatment of Alzheimer’s Disease

2016 ◽  
Vol 2016 ◽  
pp. 1-15 ◽  
Author(s):  
Francesco Panza ◽  
Vincenzo Solfrizzi ◽  
Davide Seripa ◽  
Bruno P. Imbimbo ◽  
Madia Lozupone ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Phase Ii ◽  
Animal Studies ◽  
Passive Immunization ◽  
Phase Iii ◽  
Positive Effects ◽  
Amyloid Accumulation ◽  
Phase Iii Trials ◽  
Tau Aggregation

The failure of several Phase II/III clinical trials in Alzheimer’s disease (AD) with drugs targetingβ-amyloid accumulation in the brain fuelled an increasing interest in alternative treatments against tau pathology, including approaches targeting tau phosphatases/kinases, active and passive immunization, and anti-tau aggregation. The most advanced tau aggregation inhibitor (TAI) is methylthioninium (MT), a drug existing in equilibrium between a reduced (leuco-methylthioninium) and oxidized form (MT+). MT chloride (methylene blue) was investigated in a 24-week Phase II clinical trial in 321 patients with mild to moderate AD that failed to show significant positive effects in mild AD patients, although long-term observations (50 weeks) and biomarker studies suggested possible benefit. The dose of 138 mg/day showed potential benefits on cognitive performance of moderately affected AD patients and cerebral blood flow in mildly affected patients. Further clinical evidence will come from the large ongoing Phase III trials for the treatment of AD and the behavioral variant of frontotemporal dementia on a new form of this TAI, more bioavailable and less toxic at higher doses, called TRx0237. More recently, inhibitors of tau acetylation are being actively pursued based on impressive results in animal studies obtained by salsalate, a clinically used derivative of salicylic acid.

Propentofylline in the Treatment of Alzheimer’s Disease and Vascular Dementia: A Review of Phase III Trials

1998 ◽  
Vol 9 (1) ◽  
pp. 36-43 ◽  
Author(s):  
Matthias Rother ◽  
Timo Erkinjuntti ◽  
Martin Roessner ◽  
Barbara Kittner ◽  
Jan Marcusson ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Vascular Dementia ◽  
Phase Iii ◽  
Phase Iii Trials

Combination Drug Therapy for the Treatment of Alzheimer’s Disease

2012 ◽  
Vol 7 (2) ◽  
pp. 92 ◽  
Author(s):  
X Antón álvarez ◽  
Carlos Linares ◽  
Eliezer Masliah ◽  
◽  
◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Combination Therapy ◽  
Neurodegenerative Disorder ◽  
Combined Therapy ◽  
Phase Iii ◽  
Combination Drug ◽  
Show Evidence ◽  
Phase Iii Trials ◽  
Randomised Controlled

Alzheimer’s disease (AD) is a complex and progressive neurodegenerative disorder resulting in continuous deterioration of cognition, daily living abilities and motor functions and consequently has a huge social and familial burden. To date, the drugs approved for AD treatment provide only modest symptomatic effects. At present, the combined therapy with memantine plus one cholinesterase inhibitor (ChEI) is the best option for the treatment of moderate-to-severe AD. This combination has demonstrated higher clinical efficacy than monotherapy with ChEIs, with similar safety and tolerability in several randomised-controlled clinical trials (RCTs). Recent long-term observational studies have shown that combination therapy slows the rate of cognitive and functional deterioration, delays the placement of patients in nursing homes and also provides evidence that it is more effective when initiated early. None of the drugs for AD tested in Phase III trials show evidence of disease modification. A few studies have shown that the newer drugs, particularly anti-amyloid and neurotrophic agents, may provide improved disease-modifying treatments of AD in the near future. Meanwhile, combination therapy with available drugs is the most effective AD treatment.

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