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Alzheimer’s Disease Cooperative Study

Alzheimer Disease Cooperative Study

Effective Treatments and Prevention of Alzheimers Disease: The Time is Now – Research on Aging

A research initiative of the National Institute on Aging and the University of California to assess treatments for the behavioral and cognitive symptoms of Alzheimer Disease.

Alzheimer Disease Cooperative StudyTaber’s Medical Dictionary

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Activities Of Daily Living

Several scales have been developed to measure what many regard as the most important feature of Alzheimer’s disease and where improvement will have a major positive impact on the life of the patient and their carer. Scales that measure ADL include the Progressive Deterioration Scale ,10 the Interview for Deterioration in Daily living activities in Dementia ,11 and the Alzheimer’s Disease Cooperative Study Activities of Daily living Scale .12 Measures of ADL need to be sufficiently sensitive to assess activities over a range of severities, as well as being a sensitive measure of change.

The Study Partner Requirement May Cause Unique Ethical Risks

A critical aspect of preclinical AD trial conduct is to protect participants from unwanted disclosure of genetic or biomarker information through electronic medical records . However, the risk for stigma in the home and in social situations remains in these trials and one open question is how often and with whom do preclinical AD trial participants share their testing results?

In a study of preclinical AD trial enrollment decisions, in which participants were randomly assigned to consider a hypothetical trial that did or did not require biomarker disclosure, we found that the study partner requirement was a more important barrier to enrollment when disclosure was required . The requirement was rated as more important than drug risks in the disclosure arm of this study. These preliminary data suggest that preclinical AD trial participants may be reluctant to share with others that they have biomarker evidence of AD. Some participants may face an unenviable choice: have others potentially learn information about their health they do not want shared, or forego enrolling in a study in which they wish to participate.

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Behavioral Symptoms At Baseline

Based on their own reporting, most participants experienced some behavioral symptoms, and again this did not differ between groups . The participants’ partners reported a similar overall level of symptoms .

Depression was the most commonly cited symptom by the participants followed by Apathy . Anxiety was also common and only 16.33% of participants reported Irritability. The frequency of participant- and partner-reported symptoms is displayed in figure 1.

Fig. 1

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Alzheimer’s Disease Cooperative Study

Alzheimer

The Division of Neuroscience launched the ADCS in 1991 to facilitate the testing of new drugs for the treatment of Alzheimer’s disease, particularly drugs that might not otherwise be tested by industry. A consortium of academic medical centers and clinics collaborating on the development of Alzheimers treatments and diagnostic tools, the ADCS is coordinated by the University of California, San Diego under an NIA cooperative agreement. Made up of more than 70 research sites in the United States and Canada, the ADCS investigates promising interventions. In January 2013, the NIA renewed its support of the effort for the next 5 years.

ADCS clinical trials focus on interventions that may benefit people across the disease spectrum, from the detection of Alzheimers-related brain changes in people free of symptoms to the treatment of agitation in people with Alzheimers dementia. This includes the testing of:

  • Drugs that lack patent protection
  • Drugs under patent protection that are already marketed for other uses but which might prove useful for treating people with Alzheimer’s disease

In addition to testing new therapies, the ADCS develops new evaluation instruments for clinical trials and innovative approaches to Alzheimers disease clinical trial design and analysis. The ADCS emphasizes collaboration and data sharing among its partner sites and with other research institutions.

Current ADCS Studies

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The Study Partner Requirement Is Essential To Trial Validity

Preclinical AD trials use objective cognitive tests as primary outcomes. Key secondary outcomes, however, assess subjective cognitive and functional performance. It is unclear whether subjects or their informants provide the more accurate assessment of these constructs. Traditional measures of global or functional performance, such as the Clinical Dementia Rating scale , are being used in preclinical AD trials. These rely on study partner reports. Other scales, such as those developed in the AD Cooperative Study Prevention Instrument study , include participant and study partner versions, enabling direct comparisons to determine which is optimal for preclinical AD trials.

Study partners have key roles in assuring the validity of other aspects of preclinical AD trials. One role is minimizing missing data by preventing drop out. Preclinical AD trials are lengthy and participation can be burdensome, requiring many complex visits. Previous AD prevention trials have incurred greater than expected dropout , putting statistical power at risk. In both AD dementia and MCI trials , participants lacking a spouse are at increased risk for dropout. As with trials in individuals with cognitive impairment, preclinical AD trial participants who lack a support network such as a study partner may be at increased risk for dropout.

The Study Partner Requirement Is Essential To Ensure Participant Safety And Well

To minimize cost, maximize efficiency, and understand the clinical impact of knowledge of AD gene or biomarker results, most preclinical AD trials use a transparent enrollment design . In transparent designs, the investigator discloses AD genetic or biomarker test results to the subject . Standardized approaches to do this and to monitor participant health and safety after disclosure have been developed . Prospective safety data remain limited, however, as many of the first transparent design studies are ongoing. To date , no study has reported a safety concern related to the impact of learning gene or biomarker results.

Similar findings of test-related distress exist for the disclosure of AD genetic results. The Risk Evaluation and Education in AD studies have examined the safety of disclosing apolipoprotein E 4 allele genotypes to cognitively normal middle-aged adults with a first-degree family history of AD. Learning AD genetic risk did not cause clinical anxiety or depression, but individuals who learned that they were 4 carriers experienced transient test-related distress . Although participants were not required to enroll with a study partner, discussing test results with others was associated with reduced scores on depression and anxiety measures 1 year after APOE disclosure . APOE test results were most commonly shared with spouses or other family members .

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The Study Partner Requirement Is Essential To Ensure The Scientific And Clinical Value Of Preclinical Ad Trials

Based on US Food and Drug Administration guidance, AD dementia trials assess efficacy using dual primary outcomestypically a measure of cognitive performance and a measure of global or functional performance. The latter is required to demonstrate the clinical benefit of the cognitive performance. The first AD dementia trials used instruments based only on clinician assessment of the patient to assess clinical meaningfulness . Expert consensus and research demonstrating the benefit of informant reporting , however, led to a state of the art in which AD dementia trial co-primary outcomes incorporate or exclusively rely upon study partner reporting.

In preclinical AD, FDA guidance indicates that reducing decline on a single primary outcome measure may be sufficient to achieve approval , with post-approval studies to confirm that treatments result in clinically meaningful functional benefit. Though novel approaches to demonstrating clinical benefit should be pursued, such as assessing resource utilization through medical record or claims data , long-term extension studies using traditional global or functional outcome measures seem the most probable approach. These outcome measures require a study partner. Study partner-based tools will also be vital to examining the public health implications of preclinical AD treatment, including the time to dementia onset, the number of dementia cases, and the economic burden of disease .

Amplify The Recruitment Of Minority Groups Into Ad Studies

Detecting Alzheimers Disease Earlier and Effectively – On Our Mind

The ADCS focuses its resources and attention to evaluate compounds that will ultimately benefit the well-being of AD patients. It tests agents and novel compounds that individuals, academic institutions, and drug discovery units develop, which lack patent protection, and those that are under patent protection. Furthermore, it inspects compounds under patent protection because they may be useful in treating AD, even though they were marketed for other medical needs.

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Crenezumab Fails To Slow Clinical Decline In Early Alzheimer Disease

In patients with prodromal to mild Alzheimer disease , treatment with crenezumab is well tolerated, however, it does not help reduce clinical decline. These are the findings of a study published in JAMA Neurology.

Recognizing the unmet global need in patients with AD, with no fully approved therapeutics to modify disease progression, researchers sought to evaluate the safety and efficacy of crenezumab, a humanized monoclonal immunoglobulin G-quadruplex antibody targeting amyloid-beta oligomers, in individuals with early AD.

Two global multicenter, phase 3, randomized, double-blind, parallel-group efficacy and safety studies CREAD and CREAD2 were initiated in 2016 and 2017, respectively. CREAD was conducted in 194 sites in 30 countries, whereas CREAD2 was conducted in 209 sites in 27 countries.

The primary efficacy outcome was change from baseline to week 105 in Clinical Dementia Rating-Sum of Boxes score, which measures decline in 6 clinical domains due to cognitive loss . Secondary efficacy measures included cognition evaluated by the 13-item Alzheimers Disease Assessment Scale and Mini-Mental State Examination, as well as function evaluated by the Alzheimers Disease Cooperative Study-Activities of Daily Living Inventory. Biomarker assessments were performed as well.

Between-group differences in mean change from baseline in CDR-SB score was 0.17 at week 105 in CREAD .

This article originally appeared on Neurology Advisor

Probiodrug And Alzheimers Disease Cooperative Study Receive 15 Million Usd National Institutes Of Health Grant For Us Phase 2b Core Program For Pq912

HALLE , Germany and San Diego, CA USA, 20 March 2019said Howard Feldman, MD, Professor of Neurosciences and Director of the ADCSsaid Dr. Ulrich Dauer, CEO of Probiodrug.The content of this press release is solely the responsibility of the author and does not necessarily represent the official views of the National Institutes of Health.Notes to Editors:About Probiodrug AGwww.probiodrug.deAbout PQ912 About Alzheimers diseaseThe Alzheimers Disease Cooperative Studywww.adcs.orgAbout NIH Research Project Grant Program Forward Looking StatementsInformation set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgment of Probiodrug AG as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

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One Of The Most Common Global Change Form Used In Alzheimers Disease Trials

Clinical Global Impression of Change

Validity and reliability of the Alzheimers Disease Cooperative Study-Clinical Global Impression of Change. The Alzheimers Disease Cooperative Study. Schneider LS, Olin JT, Doody RS, Clark CM, Morris JC, Reisberg B, Schmitt FA, Grundman M, Thomas RG, Ferris SH.Clinical evaluation of global change in Alzheimers disease: identifying consensus. Olin JT, Schneider LS, Doody RS, Clark CM, Ferris SH, Morris JC, Reisberg B, Schmitt FA.

MILD COGNITIVE IMPAIRMENT

Characteristics and performance of a modified version of the ADCS-CGIC CIBIC+ for mild cognitive impairment clinical trials. Schneider LS, Raman R, Schmitt FA, Doody RS, Insel P, Clark CM, Morris JC, Reisberg B, Petersen RC, Ferris SH.ADCS Prevention Instrument Project: ADCS-clinicians global impression of change scales , self-rated and study partner-rated versions. Schneider LS, Clark CM, Doody R, Ferris SH, Morris JC, Raman R, Reisberg B, Schmitt FA.

Current Study Partner Inclusion Criteria Do Not Guarantee Knowledgeable Informants

Performance

The relationship between criteria to serve as study partner and the integrity of informant data has not been established in preclinical AD, or in AD dementia for that matter. In AD dementia, spousal study partners differ from non-spousal study partners in the accuracy of cognitive assessments and in their concordance with patient ratings of quality of life . No study of informant assessment of cognitive function in preclinical AD has explored the qualifications of the study partner and whether some individuals may yield more sensitive identification of participant cognitive decline than others. Requiring study partners will preclude some potentially eligible participants from enrolling. Ensuring that those who are enrolled will provide high-integrity data will be essential to safeguarding trial value and justifying the cost of the requirement.

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Welcome To The Adcs At Ucsd

The Alzheimers Disease Cooperative Study was formed in 1991 as a cooperative agreement between the National Institute on Aging and the University of California, San Diego. The ADCS is a major initiative for Alzheimers disease clinical studies in the Federal Government, addressing treatments for both cognitive and behavioral symptoms. The ADCS is part of the NIA Division of Neurosciences effort to facilitate the discovery, development and testing of new drugs for the treatment of AD and is part of the Alzheimers Disease Prevention Initiative as well.

Validity And Reliability Of The Alzheimer’s Disease Cooperative Study

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  • Alzheimer disease and associated disorders
  • Journal of geriatric psychiatry and neurology
  • Dementia and Geriatric Cognitive Disorders Extra
  • The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry

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Ensuring That The Benefits Of Preclinical Research Apply To All Older People At Risk For Ad Dementia

Many potentially eligible preclinical AD trial participants lack a person who can fill the study partner role. While this may effectively limit the pool of participants, the requirement may also produce sample bias. Understanding the implications of this bias and ensuring that those who lack the support network needed to enroll in trials can still benefit from the knowledge gained through them will be necessary to maximize the public health impact of preclinical AD research.

Open Access License / Drug Dosage / Disclaimer

Eli Lilly’s New Drug Could Lead To Alzheimer’s Cure – Newsy

Open Access License: This is an Open Access article licensed under the terms of the Creative Commons Attribution-NonCommercial 3.0 Unported license , applicable to the online version of the article only. Distribution permitted for non-commercial purposes only. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor. The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

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Lbd Center Of Excellence

We are designated as a Research Center of Excellence by the Lewy Body Dementia Association, a leading advocacy group dedicated to raising awareness and advancing research and treatment of Lewy body dementia .Read more about this designation

Symptoms

Patients with DLB may have parkinsonian features such as slow or decreased amplitude of movements , muscle stiffness , tremor, and/or shuffling gait, or features similar to those of Alzheimer’s disease such as loss of memory.

Typically, patients with DLB have acute confusion, fluctuation of cognitive symptoms, and psychiatric disturbances such as hallucinations, delusions and depression. A diagnosis of DLB is more likely when visual hallucinations occur early in the course of the disease and are not caused by a medication.

DLB usually occurs in the late 60s, but may occur in younger people as well, particularly in familial cases.

Causes

DLB has deposits in certain areas of the brain of a protein called alpha-synuclein that form structures called Lewy bodies that are also linked to Parkinson’s disease.

Helping Study Partners Become Caregivers

A vast scientific literature on the caregiver has informed interventions to improve the lives of patients with AD dementia . Some preclinical AD participants will become clinical AD patients and need a caregiver. Little is known about the implications of who is available to preclinical AD patients for support, to aid with planning, and for assistance with instrumental ADLs with high cognitive demand. The field will ultimately need to know who these people are, if and when they change, and what if any characteristics predict their performance in these roles. Moreover, these individuals will likely need interventions to assist them in these roles, not unlike the interventions to assist dementia caregivers.

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Who We Are

The Alzheimers Disease Cooperative Study was founded by the late Leon Thal, MD, a world leader in Alzheimers research, to promote the discovery, development, and testing of new drugs for the treatment of AD. It is part of a larger AD research and treatment effort at UC San Diego, which includes the Shiley-Marcos Alzheimers Disease Research Center. Studies of AD and other neurodegenerative disorders at UC San Diego are part of the clinical and bench strength of the UC System.

The ADCS was formed in 1991 as a cooperative agreement between the National Institute on Aging

and the University of California, San Diego. The ADCS is a major initiative for Alzheimers disease clinical studies in the Federal Government, addressing treatments for both cognitive and behavioral symptoms. The ADCS is part of the NIA Division of Neurosciences effort to facilitate the discovery, development, and testing of new drugs for the treatment of AD and is part of the Alzheimers Disease Prevention Initiative as well.

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