Cognitive Assessment Battery (CAB) Beta Study
CAB
1 other identifier
observational
255
4 countries
20
Brief Summary
The overall objective of this study is to identify a 60 minute cognitive battery, for subsequent use in clinical trials, that detects cognitive deficits in early HD and late pre-manifest HD compared to controls, and that has a potential to show drug induced improvements.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 4, 2011
CompletedFirst Posted
Study publicly available on registry
February 7, 2011
CompletedAugust 3, 2012
August 1, 2012
February 4, 2011
August 2, 2012
Conditions
Keywords
Study Arms (3)
pre-manifest HD
early manifest HD
healthy controls
Eligibility Criteria
Study participants will be pre-HD, early stage HD and control subjects. The cognitive tests will be given to all participants. (only varied by order of administration) in order to determine what measures will be best at detecting cognitive changes associated with HD.
You may qualify if:
- For early HD group, subjects eligible are persons who meet the following criteria:
- Have clinical diagnostic motor features of HD; and
- Have huntingtin CAG expansion ≥ 36; and
- Have Stage 1 or Stage 2 HD, defined as UHDRS TFC scores between 7 and 13 inclusive.
- For the late pre-manifest HD group, subjects eligible are persons who meet the following criteria:
- Do not have clinical diagnostic motor features of HD; and
- Have huntingtin CAG expansion ≥ 39; and
- Have Burden of Pathology scores ≥ 300 .
- For the healthy control group, subjects eligible are persons who meet the following criteria:
- Have no known family history of HD; or,
- Have known family history of HD but have been tested for the huntingtin CAG expansion and are not at genetic risk for HD (CAG \< 36).
- For all groups, subjects eligible are persons who meet the following criteria:
- Are 25 to 55 years of age inclusive;
- Education at ISCED level 2 or higher, (see Table 5 below) and no known learning disability affecting reading ability, per investigator assessment and judgement;
- Are capable of complying with study procedures, including cognitive testing that requires spoken, written, and computer based responding;
- +8 more criteria
You may not qualify if:
- Current use of investigational drugs or participation in a clinical drug trial (unless approved by the CAB Beta study principal investigator or sponsor);
- Current intoxication, drug or alcohol abuse or dependence (see below for assessment criteria);
- Unstable or severe psychiatric disorder, including severe depression as indicated by clinician judgment or IDS-SR score ≥ 39;
- Significant history of or current medical condition with known or confirmed cognitive sequelae, such as moderate to severe traumatic brain injury, multiple sclerosis, etc;
- Use of psychostimulants (except caffeine) in the 24 hours prior to site visit;
- Use of benzodiazepines, alcohol, or other sedating drugs in the 12 hours prior to study visit;
- If using any psychoactive, psychotropic or other medications or nutraceuticals used to treat HD, the use of inappropriate (e.g., non-therapeutically high) or unstable dose over the past 30 days prior to beginning cognitive testing or throughout the study.
- Drug and Alcohol Use Assessment
- In the past six months has your alcohol or drug use caused you to miss work (or your educational obligations, if relevant) or created significant conflicts in your personal relationships?
- Over the past month, how many days would you estimate you have consumed more than 4 standard drinks per day (3 for women)?
- Over the past month, how many days would you estimate that you have used recreational drugs?
- Exclude patient if:
- #1 = YES or
- #2 + #3= \>18 or
- Patient appears intoxicated or if an alcohol odour is detected
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHDI Foundation, Inc.lead
- Monash Universitycollaborator
Study Sites (20)
University of California, San Diego
La Jolla, California, 92037, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
University of California, San Francisco
San Francisco, California, 94117, United States
University of South Florida
Tampa, Florida, 33612, United States
Rush University
Chicago, Illinois, 60612, United States
Hereditary Neurological Disease Center, Inc
Wichita, Kansas, 67206, United States
Albany Medical College
Albany, New York, 12208, United States
Columbia University
New York, New York, 10032, United States
Duke University
Durham, North Carolina, 27705, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Monash University/Bethlehem Hospital
Melbourne, Australia
Westmead Hospital
Sydney, Australia
Center for Movement Disorders
Markham, Ontario, L6B 1C9, Canada
Department of Neuropsychiatry
Edgbaston, Birmingham, B15 2FG, United Kingdom
Plymouth Hospitals NHS Trust
Derriford, Plymouth, PL6 8BX, United Kingdom
University Hospital of Wales Cardiff
Cardiff, Wales, United Kingdom
Cambridge Center for Brain Repair
Cambridge, CB2 OPY, United Kingdom
University of Manchester
Manchester, M13 9WL, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beth Borowsky, Ph.D.
CHDI Foundation, Inc.
- PRINCIPAL INVESTIGATOR
Julie C Stout, Ph.D.
Monash University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2011
First Posted
February 7, 2011
Study Start
February 1, 2011
Last Updated
August 3, 2012
Record last verified: 2012-08