publication . Article . 2015

Alzheimer’s disease progression by geographical region in a clinical trial setting

Henley, David B; Dowsett, Sherie A; Chen, Yun-Fei; Liu-Seifert, Hong; Grill, Joshua D; Doody, Rachelle S; Aisen, Paul; Raman, Rema; Miller, David S; Hake, Ann M; ...
Open Access
  • Published: 25 Jun 2015 Journal: Alzheimer's Research & Therapy, volume 7 (eissn: 1758-9193, Copyright policy)
  • Publisher: Springer Nature
  • Country: Mexico
Abstract
© 2015 Henley et al.; licensee BioMed Central. Introduction: To facilitate enrollment and meet local registration requirements, sponsors have increasingly implemented multi-national Alzheimer's disease (AD) studies. Geographic regions vary on many dimensions that may affect disease progression or its measurement. To aid researchers designing and implementing Phase 3 AD trials, we assessed disease progression across geographic regions using placebo data from four large, multi-national clinical trials of investigational compounds developed to target AD pathophysiology. Methods: Four similarly-designed 76 to 80 week, randomized, double-blind placebo-controlled tria...
Subjects
free text keywords: Clinical Research, Alzheimer's Disease, Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD), Acquired Cognitive Impairment, Brain Disorders, Neurosciences, Neurodegenerative, Clinical Trials and Supportive Activities, Aging, Dementia, Neurological, Medical and Health Sciences, Cognitive Neuroscience, Neurology, Clinical Neurology, Geographic regions, Gerontology, Disease progression, Geriatric psychiatry, medicine.medical_specialty, medicine, Disease, Placebo, business.industry, business, Clinical trial, Research
Funded by
NIH| Alzheimers Disease Neuroimaging Initiative
Project
  • Funder: National Institutes of Health (NIH)
  • Project Code: 1U01AG024904-01
  • Funding stream: NATIONAL INSTITUTE ON AGING
,
NIH| A Phase 2 Trial of AAV-NGF Gene Delivery in Alzheimers Disease
Project
  • Funder: National Institutes of Health (NIH)
  • Project Code: 1R01AG030048-01A1
  • Funding stream: NATIONAL INSTITUTE ON AGING
,
NIH| ALZHEIMERS DISEASE COOPERATIVE STUDY
Project
  • Funder: National Institutes of Health (NIH)
  • Project Code: 5U01AG010483-07
  • Funding stream: NATIONAL INSTITUTE ON AGING
,
NIH| VITAMIN E TRIAL IN PERSONS WITH DOWN SYNDROME
Project
  • Funder: National Institutes of Health (NIH)
  • Project Code: 5R01AG016381-07
  • Funding stream: NATIONAL INSTITUTE ON AGING
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publication . Article . 2015

Alzheimer’s disease progression by geographical region in a clinical trial setting

Henley, David B; Dowsett, Sherie A; Chen, Yun-Fei; Liu-Seifert, Hong; Grill, Joshua D; Doody, Rachelle S; Aisen, Paul; Raman, Rema; Miller, David S; Hake, Ann M; ...