Author Archive
Innovative Approaches for Slowing Disease Progression in Parkinson’s Disease
Monday, November 6th, 2017Chairs: Kumar Budur, MD, MS; Ibrahim Turkoz, PhD; Ira Shoulson, MD; Mark Frasier, PhD
This is a one-day symposium hosted by ISCTM, in collaboration with Michael J Fox Foundation (MJFF).
Within the past decade, there has been a significant progress in our understanding of the pathophysiology in Parkinson’s disease. With the identification of new targets, potential novel interventions and advances in the translational space, the focus has rapidly shifted from symptomatic treatments to disease modifying strategies in Parkinson’s disease. Despite significant progress in the science, there has been little discussion and agreement on clinical trial design strategies, innovative statistical analyses, and regulatory approaches for disease modification treatments in Parkinson’s disease.
This one-day symposium will include Parkinson’s disease pioneers and innovators from academia, industry, and regulatory agencies. The objective is to building consensus through collaborative and constructive discussions on strategies and clinical trial design considerations for slowing the progression in Parkinson’s disease. This is an exciting time for neurodegenerative diseases in general, and Parkinson’s disease in particular. This symposium is intended to advance the science and strategy of disease modification in Parkinson’s disease drug development, with the ultimate goal of bringing meaningful medicines to patients.
14th Annual Meeting Working Group Sessions
Thursday, November 2nd, 2017(Selecting the working group session link will direct you to specific working group’s page.)
ADAPTIVE DESIGN
Chairs: Judith Kando, PharmD; Ron Marcus, MD
The workshop will discuss a recent, innovative adaptive design study methodology ‘platform trials‘ that has been implemented in the European Prevention of Alzheimer’s Disease Study (EPAD).
ADDRESSING METHODOLOGICAL CHALLENGES IN INTERNATIONAL CNS CLINICAL TRIALS
Chairs: Amir Kalali, MD; Elizabeth Pappadopulos, PhD
Keeping with the focus on critical challenges facing international clinical trials, this work group will finalize our next topic and objectives.
ALGORITHMS/FLAGS TO IDENTIFY CLINICAL INCONSISTENCY IN THE USE OF RATING SCALES IN CNS RCTs
Chairs: Jonathan Rabinowitz, PhD; Nina R. Schooler, PhD
The working group will complete the compilation of the flags for the Montgomery-Asberg Depression Scale (MADRS) and begin working on flags for the Personal and Social Performance (PSP) scale.
ASSESSING ABUSE LIABILITY POTENTIAL
Chairs: Marta Sokolowska, PhD; Michael Klein, PhD; Beatrice Setnik, PhD
The functional excipient conundrum: Identifying nonclinical and clinical approaches to characterize the safety and effectiveness of excipients in abuse deterrent formulations
The development of abuse deterrent formulations is an important consideration in mitigating the risks associated with inappropriate use of opioid drug products. Many such formulations contain functional excipients that render the formulation less attractive, particularly when administered via non-intended routes. Additional studies may be required to examine safety of functional excipients administered via the intended as well as unintended (intranasal or intravenous) administration routes.
This workshop will 1) discuss the profiles of several different excipients used for abuse deterrent formulations, 2) discuss the changing regulatory framework with the need to evaluate safety of excipients administered via non-intended routes, 3) identify key study types that could be used to elucidate the safety and efficacy of an excipient, and 4) identify when such studies can be safely conducted in humans.
BEHAVIORAL AND PSYCHIATRIC SYMPTOMS IN DEMENTIA (BPSD)
Agitation Subgoup Session
Chairs: Cedric O’Gorman, MD; Paul Rosenberg, MD
The Agitation associated with Alzheimer’s Disease subgroup of the ISCTM BPSD working group will convene to further advance its plans to develop a consensus amongst academia, industry and regulators pertaining to recommendations for optimal trial methodology that could allow for the discovery of medications which may help relieve symptoms of agitation associated with AD. Specific objectives for discussion at the meeting will include the development of a publication plan (including the writing of a white paper), ongoing conference attendance considerations, as well as the possibility of multi-partner initiatives to draw attention to the considerable unmet need associated with agitation in Alzheimer’s disease.
BEHAVIORAL AND PSYCHIATRIC SYMPTOMS IN DEMENTIA (BPSD)
Apathy Subgroup Session (Note- session takes place Tuesday MORNING – 8:30-11:30)
Chairs: Krista Lanctot, PhD; David Miller, MD
During this session we will:
-Discuss the apathy consensus meeting survey process
-Discuss the results of the preliminary survey:
-identification of areas of agreement
-identification of areas of disagreement
-Review next steps for diagnostic criteria for diagnostic criteria consensus conference
PREVENTION TRIALS IN ALZHEIMER’S DISEASE – DESIGN CONSIDERATIONS
(formerly called – COGNITIVE ASSESSMENT IN ALZHEIMER’S DISEASE)
Chairs: Holly Posner, MD; Philip Harvey, PhD
Current treatment efforts in Alzheimer’s disease (AD) are focused on prevention of the illness, given the consistent failures in treatments targeted at existing disease. Prevention trials are challenging for several reasons, including in domains of subject selection, outcomes measurement, and trial duration. Subject selection in previous trials has included participants who were related to AD cases or cases with subclinical cognitive changes not meeting criteria for AD. Outcomes measurement is challenging because participants who do not have detectable cognitive changes cannot be assessed with standard outcomes measures. Trial duration is challenging because of the unclear time course of development of AD in the targeted populations and the cost of longer trials.
The current working group meeting will discuss alternative strategies for selection of participants, outcomes assessments, and duration considerations for trials. Brief presentations, followed by discussion, will be focused on these issues and other considerations raised by the attendees.
ESTIMANDS AND MISSING DATA
Chairs: Pilar Lim, PhD; Elena Polverejan, PhD
The Estimands and Missing Data Working Group will continue to develop the structured framework with which to implement the ICH E9(R1) draft guidance on “Estimands and Sensitivity Analysis in Clinical Trials”. This structured framework can be used by clinical teams when designing a clinical study according to the guidance. The first indication that is being tackled is Major Depressive Disorder.
LATE-ONSET DEPRESSION: A Distinct Indication?
Chair: Heddie Martynowicz, DM, MS
“Major depressive disorder (MDD), is a serious, recurrent, and disabling psychiatric illness associated with excess mortality and with years of potential life lost. This session will explore clinical distinctions between late-onset depression and adult MDD and potential regulatory implications.”
NEGATIVE SYMPTOMS
Chairs: Stephen Marder, MD; David Daniel, MD
The workgroup will re-examine prior recommendations on clinical trial methodology for studying treatments for negative symptoms. The re-examination will be informed by data from recent trials. In addition, the group will explore designs for drugs that may be used as monotherapy for psychotic and negative symptoms.
ORPHAN DISEASES (Closed)
Chairs: Joan Busner, PhD; Judy Dunn, PhD; Ravi Anand, MD
SESSION PREPARATION-OPEN TO 14TH ANNUAL MEETING ORPHAN DISEASE CHAIRS, SPEAKERS AND PANELISTS ONLY.
Methodological Challenges Related to Rare and Orphan Disease Drug Development
Thursday, November 2nd, 2017Chairs: Joan Busner, PhD; Judy Dunn, PhD; Ravi Anand, MD
Drug development for rare and orphan CNS diseases is associated with a unique set of methodological challenges, often underappreciated, that can delay trial completion, complicate interpretation, and ultimately threaten trial success. This session will provide a high-level, candid, examination of challenges and potential strategies for overcoming them. The session will cover the role of patient advocacy in meeting challenges, statistical considerations in small N trials, emerging trends in data submission requirements, challenges in identifying disease-specific and patient-centric outcomes, logistical challenges including far-spread patients, illness-related travel restriction, and lack of research-trained investigators, and the FDA perspective including public health considerations, pediatric regulations, and incentives to developers. As the first ISCTM session to address orphan and rare disease drug development; we anticipate high levels of audience engagement and discussion.
14th Annual Scientific Meeting – Speakers’ Corner
Wednesday, August 2nd, 2017Thank you for agreeing to participate as a presenter and/or chairperson at the upcoming ISCTM 14th Annual Scientific Meeting. This page contains all the links you will need for submitting information to the ISCTM, as well as information we hope you find helpful for your planning.
Dates/Location
20-22 February 2018
The Fairmont
Washington DC, USA
(Housing to be booked through ISCTM during registration process. Do not contact the hotel directly.
Details below)
STEP 1: Complete the Online Confirmation and Agreement
STEP 2: Please Email Biographical Paragraph and Photo
2500 characters max (including spaces)
STEP 3: Register for the Meeting
Registration announcements have been sent. Selecting Register from that email will direct you to the fee-waived Speaker Registration path. You will have the opportunity to book your housing during the registration process. Do not contact the hotel. To have the email resent please email the Secretariat.
STEP 4: Please Email Abstract
Abstract, for inclusion in the program book, should be submitted after the first session development call with chairs, but no later than 10 January 2018. Abstract should be in paragraph form,
< 300 words and contain no tables.
STEP 5: Presentation Submission Schedule
— Draft: Chairs will advise according to each segment’s agenda development telecon schedule.
— Final: Bring flash drive to onsite registration desk the morning of your session, no later than 30 minutes prior to the start of the meeting day.
STEP 6: Chairs/Co-Chairs – Publication Information
To facilitate dissemination of information discussed during ISCTM meetings, we encourage publications from ISCTM sessions. Chairs will discuss during the session development calls. (Output category specifications)
Travel Arrangements:
In order to meet ISCTM’s fiscal responsibilities, the Society endeavors to operate its meetings as close to break even as possible, hopefully in the black. The Executive does not wish to raise additional revenue through increasing registration fees, so we must keep a close watch on expenses. Therefore, we ask speakers who will request reimbursement to keep this in mind when arranging travel, specifically, to book flights enough ahead of travel dates to take advantage of the lower fares. (ISCTM Speaker Reimbursement Policy)
Preliminary Agenda:
| Day 1: Tuesday, 20 February 2018 | |
| 11:00-5:30 | Onsite Registration Open |
| 1:00-3:45 | Unresolved Problems in Neuroscience Drug Development – Point/Counterpoint |
| 4:25-6:00 | Working Group Sessions |
| 6:00-7:00 | Welcome Reception |
| Day 2: Wednesday, 21 February 2018 | |
| 7:15 | Registration opens/Continental Breakfast |
| 8:15-Noon | |
| Noon-2:00 | ISCTM Annual Business Meeting/Luncheon |
| 2:10-5:50 | |
| 6:00-8:00 | Poster Session/Reception |
| Day 3: Thursday, 22 February 2018 | |
| 7:15 | Registration opens/Continental Breakfast |
| 8:15 | |
| Meeting Adjourns | |
ISCTM Contact Information
George Haig – Chair, Scientific Program Committee
Carlotta McKee – Executive Director, ISCTM
Mary Bea Harding – Executive Assistant, ISCTM
Robin Patterson – Administrative Assistant, ISCTM
Phone: +1.615.383.7688
17th Annual Scientific Meeting Speaker Confirmation
Wednesday, August 2nd, 2017Protected: BPSD Project Materials
Friday, July 14th, 2017BPSD WG Project Page
Thursday, July 13th, 2017This page will serve as the project management page for all related BPSD Working Group activities
- WG members may access shared materials through link below to drop-box.
- If you wish to upload materials to the online shared file, please email pdf to Linda Hutchinson
- For non-released material, link will be provided to original article page for login.
BPSD Working Group Objectives
This working group is being convened with the support of ISCTM to focus on the methodological challenges facing the development of treatments for the Behavioral and Psychiatric Symptoms of Dementia (BPSD).
- Based on broadly supported feedback from Work Group meetings, two subgroups have been formed addressing BPSD treatment needs: Apathy and Agitation;
- Convey critical importance of treating BPSD, summarizing the value proposition for identification, management, and development and/or use of appropriate drug therapies;
- Summarize the literature and existing state of the art to document the potential impact on patient and caregiver function and well-being, derived from amelioration of neuro-psychiatric symptoms;
- Review of lessons learned from ongoing and prior clinical trials for BPSD;
- Propose innovative trials designs that improve data quality, strategies to accelerate drug development, and incorporate regulatory viewpoints and considerations;
- Shared actions for the two BPSD Sub-groups addressing Agitation and Apathy include:
– Continuing collaboration with ISTAART NPS PIA;
– Proposal development for presentations/sessions at ISCTM and other professional/scientific learned societies;
– Regularly scheduled meetings of the two Working sub-groups (teleconference and face-to-face)
– Develop sub-group specific mission statements, goals, and objectives to guide a road-map strategy that moves the field towards consensus supported methodological recommendations.
BPSD Working Group Steering Committee
Larry Ereshefsky
Krista Lanctot
Stephen Marder
David Miller
Cedric O’Gorman
Luca Pani
Paul Rosenberg
Subgroup: Agitation associated with Dementia, including Alzheimer’s Disease
Chairs: Cedric O’Gorman, Paul Rosenberg
Mission Statement
To address the need for safe and effective medications to treat agitation associated with dementia and to gain consensus amongst experts on a roadmap for optimal clinical trial methodology which may garner regulatory approval.
Deliverable/Timeline
—White Paper – Summer 2018
Update post-ISCTM annual meeting on February 20th 2018.
Thanks to all who attended the working session of the agitation in Alzheimer’s disease BPSD subgroup. Fruitful and stimulating discussion occurred. Further progress has been made in the development of a consensus white paper addressing the clinical development of much needed medications to treat Alzheimer’s disease agitation. The proposed white paper had been divided into sections, and individuals have now been formally assigned to lead the writing of these sections. A deadline of July 1st 2018 has been set for the accomplishment of the writing of all these sections. ~ Cedric O’Gorman and Paul Rosenberg.
Link to all BPSD Project Materials
Subgroup: Apathy subgroup
Chairs: David Miller, Krista Lanctot
Apathy as a Behavioural and Psychological Symptom in Dementia (BPSD) has increasingly been the focus of research over the last 10 years. This interest has led to the publication of provisional diagnostic criteria and stimulated interest in this syndrome as a treatment target for both Alzheimer’s disease and related dementias. Apathy can both precede and emerge concurrently with cognitive impairment and other BPSD. The Apathy Working Group brings together industry, academic and drug regulatory experts. This expertise will be used to define the relevance of apathy and to better understand, recognize and manage apathy within BPSD and provide a basis for further research.
Deliverable/Timeline
Link to all BPSD Project Materials
2018 New Investigator Award: Submission and Eligibility Guidelines
Thursday, July 13th, 2017The International Society for CNS Clinical Trials and Methodology has created a program to recognize promising new investigators across the broad range of methodological, regulatory and substantive programmatic interests of the society. Up to four (4) NI Award applicants will be selected each year. Appointments as NI Awardees will be for one year.
(Previous Award Recipients)
Eligibility Criteria: Early career (second-year or beyond postdocs or those within 8 years of the completion of training) academic or (more…)
2017 Autumn Conference Posters
Wednesday, June 21st, 2017PDFs and Abstracts are listed alphabetically by author.
14th Annual Scientific Meeting Poster Submission Form
Tuesday, April 4th, 2017ABSTRACT DEADLINE EXTENDED TO THURSDAY, 7 DECEMBER.
ISCTM 14th Annual Scientific Meeting
20-22 February 2018
The Fairmont
Washington DC
IT IS IMPORTANT THAT YOU REVIEW GUIDELINES. Revised December 2016.
The ISCTM Poster Committee is calling for Abstracts with content pertaining to significant CNS methodological problems-solutions relevant to the meeting program topics or previous ISCTM topics. ABSTRACTS AND POSTERS MUST BE FREE OF COMMERCIAL BIAS OR PROMOTION. (Please see Guidelines)
Submission Process: You may submit your Abstract online by filling out the form provided below or by EMAIL. If submitting by email, please be sure to include all requested information. You will receive a confirmation of receipt.
Submission Deadline: 7 December 2017
Notification: 21 December 2017
Meeting Dates: 20-22 February 2018
Formal poster session: Wednesday, 21 February 2018
Presenter must register for the meeting and attend the formal session. Poster session is part of the Scientific Program. ISCTM recommends that the poster be presented by the first author. If that is not possible, please designate which author will be present at the session to discuss the work with attendees.
Poster set up: Wednesday, 21 February, AM. Poster order (board number) will be included in the Poster Abstract section of the Meeting Program booklet. Numbers will not be distributed prior to the meeting.
Poster removal: Posters should be removed at the conclusion of the formal Poster Session.
Location: The Fairmont, Washington DC
Poster Review: Certificates of Recognition will be awarded. In order to facilitate judging, please forward .pdf of poster to Secretariat for review by judging committee by Tuesday, 13 February.
Poster Dimensions: Up to 4’ (122 cm) by 6’ (183 cm) Landscape orientation
As the poster session is small, it is not necessary to include the presentation number on your poster.
(Refer to Guidelines link above for additional formatting information)
Shipping Information:
The Fairmont, Washington DC
2401 M Street, NW
Washington, DC 20037
Attention: Guest- Receiver’s Name
Guest’s arrival date at hotel
ABSTRACT SUBMISSION FORM
Submission should contain:
- Title, all authors, author affiliations
- Methodological Question being addressed
- Abstract content should be formatted into sections as outlined in the Guidelines, with word count up to 500 exclusive of title, authors, affiliations.
- Please review Guidelines before submitting abstract.
If you are submitting abstract on behalf of author, please be sure to enter your name and email under Submitter. Thank you.