Alzheimer's disease research in the context of the national plan to address Alzheimer's disease

Snyder, Heather M.; Hendrix, James A.; Bain, Lisa J.; Carrillo, María C.

doi:10.1016/j.mam.2015.06.005

Cited by 16 publications

(17 citation statements)

References 81 publications

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“…President Obama articulated a goal of cure or meaningful treatment for AD by the year 2025 [5] , [36] . A recent analysis of AD drug development showed that it takes on average 13 years for a candidate treatment to move from laboratory to FDA review and 10 years for an agent to navigate the clinical development period from start of phase I to end of FDA review [37] .…”

Section: Discussionmentioning

confidence: 99%

Alzheimer's disease drug development pipeline: 2017

Cummings

Lee

Mortsdorf

et al. 2017

A&D Transl Res & Clin Interv

365

275

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IntroductionThere is an urgent need to develop new treatments for Alzheimer's disease (AD) and to understand the drug development process for new AD therapies.MethodsWe assessed the agents in the AD pipeline as documented in clinicaltrials.gov for phase I, phase II, and phase III, accessed 1/5/2017.ResultsThere are 105 agents in the AD treatment development pipeline, of which 25 agents are in 29 trials in phase I, 52 agents are in 68 trials in phase II, and 28 agents are in 42 trials in phase III. Seventy percent of drugs in the AD pipeline are disease-modifying therapies (DMTs). Fourteen percent are symptomatic cognitive enhancers, and 13% are symptomatic agents addressing neuropsychiatric and behavioral changes (2% have undisclosed mechanisms). Most trials are sponsored by the biopharmaceutical industry. Trials include patients with preclinical AD (cognitively normal with biomarker evidence of AD), prodromal AD (mild cognitive symptoms and biomarker evidence of AD), and AD dementia. Biomarkers are included in many drug development programs particularly those for DMTs. Thirteen of 46 phase II DMT trials have amyloid imaging as an entry criterion, and 10 of 28 phase III trials incorporate amyloid imaging for diagnosis and entry. A large number of participants are needed for AD clinical trials; in total, 54,073 participants are required for trials spanning preclinical AD to AD dementia. When compared with the 2016 pipeline, there are eight new agents in phase I, 16 in phase II, and five in phase III.DiscussionThe AD drug development pipeline has 105 agents divided among phase I, phase II, and phase III. The trials include a wide range of clinical trial populations, many mechanisms of action, and require a substantial number of clinical trial participants. Biomarkers are increasingly used in patient identification and as outcome measures, particularly in trials of DMTs.

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Section: Discussionmentioning

confidence: 99%

Alzheimer's disease drug development pipeline: 2017

Cummings

Lee

Mortsdorf

et al. 2017

A&D Transl Res & Clin Interv

365

275

View full text Add to dashboard Cite

show abstract

“…There are also differences in the expected life time: people with severe mental disorders die an average 10-15 years earlier than the general population (World Health Organization, 2015b). However, there is potential for success, and experts in this field express optimism that the set goals are achievable (Snyder et al, 2015). Their optimism is based on the fact that the delay in the appearance of symptoms for only 5 years can reduce the cost of treatment of the disease by 50%.…”

Section: Strengthening Coordination and Research To Raise Awareness Omentioning

confidence: 99%

Prospects of Effective Management of Dementia for Ukraine: Learning from International Experience

Khudoba¹

2018

EJIS

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Despite the scale of the spread and economic impact of dementia on families, caregivers and the community as a whole, the disease of dementia is either not discussed at all or is not a priority in low-economic countries. The purpose of this study is to attract attention of policy and decision makers to dementia problems in Ukraine to facilitate developing systems of health care and social care for people living with dementia and their caregivers. It is one of the first attempts to look at the problem of dementia in Ukraine from the public administration point of view in different aspects and directions, as well as an attempt to initiate a professional discussion with policy and decision makers on issues of developing and implementing a strategy for people living with dementia and their families. Since Ukraine is not yet on the list of the countries which joined the global program of counteracting dementia and this problem is not relevant to Ukraine , we tried to make a short comparative analysis of Ukraine with countries for which dementia is one of the national priorities (France, the Netherlands, the USA, the UK, Norway and Australia).

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“…January 4, 2011, in Washington, Mr. President Obama wrote his name with his left hand on the National Alzheimer's Project Act (NAPA), a Public Law 111-375 (S.3036), to "prevent or effectively treat Alzheimer's disease by 2025." [118][119][120]. NAPA also says "The Project shall expire December 31, 2025", at the sunset, as it is called in the law [118].…”

Section: The Year 2025 Is Nearmentioning

confidence: 99%

The amyloid hypothesis is too good to be true

Kurkinen¹

2017

Alzheimers Dement Cogn Neurol

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Alzheimer's disease research in the context of the national plan to address Alzheimer's disease

Cited by 16 publications

References 81 publications

Alzheimer's disease drug development pipeline: 2017

Alzheimer's disease drug development pipeline: 2017

Prospects of Effective Management of Dementia for Ukraine: Learning from International Experience

The amyloid hypothesis is too good to be true

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