Ana Graf
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View article: Impact of learning APOE genotype on cognitively unimpaired adults: a pre-screening cohort study of the Alzheimer’s Prevention Initiative Generation Study 1
Impact of learning APOE genotype on cognitively unimpaired adults: a pre-screening cohort study of the Alzheimer’s Prevention Initiative Generation Study 1 Open
The National Institute on Aging, Alzheimer's Association, Banner Alzheimer's Foundation, GHR Foundation, F-Prime Biomedical Research Initiative (FBRI), and Novartis Pharma.
View article: Understanding the impact of amyloid beta targeted therapies on biomarkers and clinical endpoints in Alzheimer's disease
Understanding the impact of amyloid beta targeted therapies on biomarkers and clinical endpoints in Alzheimer's disease Open
The Alzheimer's disease (AD) scientific field continues to make significant advances in early detection and treatments, which importantly rest on advances in our fundamental understanding of AD pathobiology and its contribution to cognitiv…
View article: Operationalizing selection criteria for clinical trials in Alzheimer's disease: Biomarker and clinical considerations: Proceedings from the Alzheimer's Association Research Roundtable (AARR) Fall 2021 meeting
Operationalizing selection criteria for clinical trials in Alzheimer's disease: Biomarker and clinical considerations: Proceedings from the Alzheimer's Association Research Roundtable (AARR) Fall 2021 meeting Open
The design of clinical trials in Alzheimer's disease (AD) must consider the development of new plasma, cerebrospinal fluid (CSF), and imaging biomarkers. They must also define clinically meaningful outcomes for patients and set endpoints t…
View article: Application of the revised criteria for diagnosis and staging of Alzheimer's disease: Drug development and clinical practice
Application of the revised criteria for diagnosis and staging of Alzheimer's disease: Drug development and clinical practice Open
The newly proposed revised criteria for diagnosis and staging of Alzheimer's disease (AD) by the Alzheimer's Association (AA) Workgroup represent a significant milestone in the field. These criteria offer objective measures for diagnosing …
View article: Reversibility of cognitive worsening observed with BACE inhibitor umibecestat in the Alzheimer's Prevention Initiative (API) Generation Studies
Reversibility of cognitive worsening observed with BACE inhibitor umibecestat in the Alzheimer's Prevention Initiative (API) Generation Studies Open
INTRODUCTION The Alzheimer's Prevention Initiative (API) Generation Studies evaluated the BACE inhibitor umibecestat for Alzheimer's disease (AD) prevention. The studies were terminated early, and the reversibility of umibecestat's side ef…
View article: Revised criteria for the diagnosis and staging of Alzheimer’s disease
Revised criteria for the diagnosis and staging of Alzheimer’s disease Open
View article: Revised criteria for diagnosis and staging of Alzheimer's disease: Alzheimer's Association Workgroup
Revised criteria for diagnosis and staging of Alzheimer's disease: Alzheimer's Association Workgroup Open
The National Institute on Aging and the Alzheimer's Association convened three separate work groups in 2011 and single work groups in 2012 and 2018 to create recommendations for the diagnosis and characterization of Alzheimer's disease (AD…
View article: Effects of the active amyloid beta immunotherapy CAD106 on PET measurements of amyloid plaque deposition in cognitively unimpaired <i>APOE</i> ε4 homozygotes
Effects of the active amyloid beta immunotherapy CAD106 on PET measurements of amyloid plaque deposition in cognitively unimpaired <i>APOE</i> ε4 homozygotes Open
INTRODUCTION Alzheimer's Prevention Initiative Generation Study 1 evaluated amyloid beta (Aβ) active immunotherapy (vaccine) CAD106 and BACE‐1 inhibitor umibecestat in cognitively unimpaired 60‐ to 75‐year‐old participants at genetic risk …
View article: Human CSF pharmacoproteomics establishes in vivo‐relevant BACE1 substrates as pharmacodynamic biomarkers for chronic BACE inhibition in clinical trials
Human CSF pharmacoproteomics establishes in vivo‐relevant BACE1 substrates as pharmacodynamic biomarkers for chronic BACE inhibition in clinical trials Open
Background BACE1 is a major drug target for Alzheimer’s disease, but several late‐stage clinical trials with BACE‐inhibitors were associated with adverse events, most notably worsening in measures of cognitive function. Inhibition of BACE1…
View article: Operationalizing selection criteria for clinical trials in Alzheimer's disease: Biomarker and clinical considerations
Operationalizing selection criteria for clinical trials in Alzheimer's disease: Biomarker and clinical considerations Open
Alzheimer's disease (AD) staging criteria lack standardized, empirical description. Well‐defined AD staging criteria are an important consideration in protocol design, influencing a more standardized inclusion/exclusion criteria and defini…
View article: Rationale for the selection of dual primary endpoints in prevention studies of cognitively unimpaired individuals at genetic risk for developing symptoms of Alzheimer’s disease
Rationale for the selection of dual primary endpoints in prevention studies of cognitively unimpaired individuals at genetic risk for developing symptoms of Alzheimer’s disease Open
View article: Rationale for the selection of dual primary endpoints in prevention studies of cognitively unimpaired individuals at genetic risk for developing symptoms of Alzheimer’s disease
Rationale for the selection of dual primary endpoints in prevention studies of cognitively unimpaired individuals at genetic risk for developing symptoms of Alzheimer’s disease Open
Background : There is a critical need for novel primary endpoints designed to detect early and subtle changes in cognition in clinical trials targeting the asymptomatic (preclinical) phase of Alzheimer’s disease (AD). The Alzheimer’s Preve…
View article: Current understanding of AD pathophysiology and impact of amyloid beta–targeted treatments on biomarkers and clinical endpoints
Current understanding of AD pathophysiology and impact of amyloid beta–targeted treatments on biomarkers and clinical endpoints Open
Alzheimer's disease (AD) is a fatal, neurodegenerative disease whose pathogenesis includes the buildup of amyloid beta (Aß; one of the defining brain changes of AD) years before clinical symptoms appear. Anti-Aß therapeutics that target th…
View article: Current understanding of AD pathophysiology and impact of amyloid‐beta targeted treatments on biomarkers and clinical endpoints
Current understanding of AD pathophysiology and impact of amyloid‐beta targeted treatments on biomarkers and clinical endpoints Open
The Spring 2022 Alzheimer's Association's Research Roundtable (AARR) convened leaders from around the world to discuss the topic, "Current Understanding of AD Pathophysiology & Impact of Amyloid-beta Targeted Treatments on Biomarkers and C…
View article: The API Generation program: Umibecestat treatment and discontinuation effects on hippocampal and whole brain volumes in the overall population and amyloid‐negative APOE4 homozygotes
The API Generation program: Umibecestat treatment and discontinuation effects on hippocampal and whole brain volumes in the overall population and amyloid‐negative APOE4 homozygotes Open
Background In addition to early mild non‐progressive cognitive worsening, BACE inhibitors have been associated with early non‐progressive reductions in hippocampal and whole brain volume in trial participants with elevated amyloid (A+, Ega…
View article: The Alzheimer’s prevention initiative Generation program: A global perspective on best practices for site support and engagement to accelerate participant recruitment
The Alzheimer’s prevention initiative Generation program: A global perspective on best practices for site support and engagement to accelerate participant recruitment Open
Background The API Generation Program consists of two trials: Generation Studies 1 and 2. Generation Study 1 enrolled cognitively unimpaired APOE4 homozygotes (HMs) ages 60‐75; Generation Study 2 enrolled cognitively unimpaired APOE4 carri…
View article: The Generation program: Baseline characteristics of cognitively unimpaired APOE4 carriers recruited for Generation study 1 and Generation study 2
The Generation program: Baseline characteristics of cognitively unimpaired APOE4 carriers recruited for Generation study 1 and Generation study 2 Open
Background The Alzheimer Prevention Initiative (API) Generation Program evaluated the effectiveness of the BACE1 inhibitor, umibecestat, and the active immunotherapy, CAD106, in delaying the onset of AD symptoms in APOE4 carriers. The Gene…
View article: The Alzheimer’s Prevention Initiative Composite Cognitive Test: a practical measure for tracking cognitive decline in preclinical Alzheimer’s disease
The Alzheimer’s Prevention Initiative Composite Cognitive Test: a practical measure for tracking cognitive decline in preclinical Alzheimer’s disease Open
Background There is growing interest in identifying sensitive composite cognitive tests to serve as primary endpoints in preclinical Alzheimer’s disease (AD) treatment trials. We reported previously a composite cognitive test score sensiti…
View article: F2‐03‐04: ASSESSING CLINICAL MEANINGFULNESS OF OUTCOMES IN THE ALZHEIMER'S PREVENTION INITIATIVE GENERATION PROGRAM
F2‐03‐04: ASSESSING CLINICAL MEANINGFULNESS OF OUTCOMES IN THE ALZHEIMER'S PREVENTION INITIATIVE GENERATION PROGRAM Open
The Alzheimer's Prevention Initiative Generation Program consists of two trials: Generation Studies 1 and 2. Generation Study 1 is recruiting cognitively unimpaired APOE4 homozygotes ages 60-75; Generation Study 2 is recruiting cognitively…
View article: FTS3‐01‐01: UMIBECESTAT (CNP520) IS NOT ASSOCIATED WITH CHANGES IN HIPPOCAMPAL MORPHOLOGY IN RATS OR CHANGES IN CSF AD BIOMARKERS IN HUMANS TREATED FOR 3 MONTHS
FTS3‐01‐01: UMIBECESTAT (CNP520) IS NOT ASSOCIATED WITH CHANGES IN HIPPOCAMPAL MORPHOLOGY IN RATS OR CHANGES IN CSF AD BIOMARKERS IN HUMANS TREATED FOR 3 MONTHS Open
reading level and WMH interaction (b¼-.030,[-.061,.002]) on processing speed, indicating that above a specific reading level, WMH had a negative overall effect on speed.Conclusions: Quality of education, as measured by reading level, moder…
View article: The Alzheimer's Prevention Initiative Generation Program: Study design of two randomized controlled trials for individuals at risk for clinical onset of Alzheimer's disease
The Alzheimer's Prevention Initiative Generation Program: Study design of two randomized controlled trials for individuals at risk for clinical onset of Alzheimer's disease Open
Introduction Alzheimer's disease (AD) pathology, including the accumulation of amyloid beta (Aβ) species and tau pathology, begins decades before the onset of cognitive impairment. This long preclinical period provides an opportunity for c…
View article: The <scp>BACE</scp> ‐1 inhibitor <scp>CNP</scp> 520 for prevention trials in Alzheimer's disease
The <span>BACE</span> ‐1 inhibitor <span>CNP</span> 520 for prevention trials in Alzheimer's disease Open
View article: Measuring cognition and function in the preclinical stage of Alzheimer's disease
Measuring cognition and function in the preclinical stage of Alzheimer's disease Open
The Alzheimer's Association's Research Roundtable met in November 2016 to explore how best to measure changes in cognition and function in the preclinical stage of Alzheimer's disease. This review will cover the tools and instruments curre…
View article: [O2–17–05]: RATIONALE FOR CNP520 DOSE SELECTION FOR THE PIVOTAL CLINICAL PROGRAM IN PRECLINICAL AD
[O2–17–05]: RATIONALE FOR CNP520 DOSE SELECTION FOR THE PIVOTAL CLINICAL PROGRAM IN PRECLINICAL AD Open
The pivotal program for the BACE inhibitor CNP520 comprises 2 studies in cognitively normal people who, on the basis of their age, genetics (APOE4) and presence of elevated amyloid are at high risk of developing symptoms of AD. Doses were …
View article: [P1–051]: RESULTS FROM A 3‐MONTH STUDY IN HEALTHY SUBJECTS AGED 60 YEARS WITH THE BACE INHIBITOR CNP520
[P1–051]: RESULTS FROM A 3‐MONTH STUDY IN HEALTHY SUBJECTS AGED 60 YEARS WITH THE BACE INHIBITOR CNP520 Open
The BACE inhibitor CNP520 is under clinical development as a potential disease-modifying treatment in asymptomatic subjects at risk for Alzheimer's disease. A 3-month dose-ranging safety and tolerability study in healthy subjects ≥60 years…
View article: Active Aβ immunotherapy CAD106 in Alzheimer's disease: A phase 2b study
Active Aβ immunotherapy CAD106 in Alzheimer's disease: A phase 2b study Open
Introduction This randomized, double‐blind, placebo‐controlled, 90‐week study assessed safety, tolerability, and immunogenicity of CAD106 with/without adjuvant in patients with mild Alzheimer's disease. Methods One hundred twenty‐one patie…
View article: Long-term treatment with active Aβ immunotherapy with CAD106 in mild Alzheimer's disease
Long-term treatment with active Aβ immunotherapy with CAD106 in mild Alzheimer's disease Open
Introduction: CAD106 is designed to stimulate amyloid-β (Aβ)-specific antibody responses while avoiding T-cell autoimmune responses. The CAD106 first-in-human study demonstrated a favorable safety profile and promising antibody response. W…
View article: Long-term treatment with active Aβ immunotherapy with CAD106 in mild Alzheimer’s disease
Long-term treatment with active Aβ immunotherapy with CAD106 in mild Alzheimer’s disease Open