Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
255 participants
OBSERVATIONAL
2011-02-28
Brief Summary
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Detailed Description
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There will be paper and pencil and computerized cognitive tests given over a six week period to non-HD control subjects, pre-manifest HD and early manifest HD subjects.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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pre-manifest HD
No interventions assigned to this group
early manifest HD
No interventions assigned to this group
healthy controls
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Have clinical diagnostic motor features of HD; and
2. Have huntingtin CAG expansion ≥ 36; and
3. Have Stage 1 or Stage 2 HD, defined as UHDRS TFC scores between 7 and 13 inclusive.
2. For the late pre-manifest HD group, subjects eligible are persons who meet the following criteria:
1. Do not have clinical diagnostic motor features of HD; and
2. Have huntingtin CAG expansion ≥ 39; and
3. Have Burden of Pathology scores ≥ 300 .
3. For the healthy control group, subjects eligible are persons who meet the following criteria:
1. Have no known family history of HD; or,
2. 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).
4. For all groups, subjects eligible are persons who meet the following criteria:
1. Are 25 to 55 years of age inclusive;
2. Education at ISCED level 2 or higher, (see Table 5 below) and no known learning disability affecting reading ability, per investigator assessment and judgement;
3. Are capable of complying with study procedures, including cognitive testing that requires spoken, written, and computer based responding;
4. Are ambulatory and do not require skilled nursing care;
5. Have not had cognitive testing for 2 or more months prior to the participation in cognitive testing for the current study;
6. Will not have cognitive testing for other purposes during the course of the study; and,
7. Are capable of providing informed consent.
Education inclusion criterion definition based on ISCED ISCED level 2: Completion of lower secondary general
Australia: Completed junior high school/year 9
Canada: Completed junior high school or junior secondary school or year 9
United Kingdom: Completed Key Stage 3 of secondary school or 'O' levels, or Year 10/Fourth Form (England/Wales); Year 11 (Northern Ireland); 3rd year secondary (Scotland)
United States: Completed junior high school or grade 9
\-
Exclusion Criteria
2. Current intoxication, drug or alcohol abuse or dependence (see below for assessment criteria);
3. Unstable or severe psychiatric disorder, including severe depression as indicated by clinician judgment or IDS-SR score ≥ 39;
4. Significant history of or current medical condition with known or confirmed cognitive sequelae, such as moderate to severe traumatic brain injury, multiple sclerosis, etc;
5. Use of psychostimulants (except caffeine) in the 24 hours prior to site visit;
6. Use of benzodiazepines, alcohol, or other sedating drugs in the 12 hours prior to study visit;
7. 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
1. 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?
2. Over the past month, how many days would you estimate you have consumed more than 4 standard drinks per day (3 for women)?
3. 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
25 Years
55 Years
ALL
Yes
Sponsors
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Monash University
OTHER
CHDI Foundation, Inc.
OTHER
Responsible Party
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Principal Investigators
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Julie C Stout, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Monash University
Beth Borowsky, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
CHDI Foundation, Inc.
Locations
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University of California, San Diego
La Jolla, California, United States
University of California, Los Angeles
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
University of South Florida
Tampa, Florida, United States
Rush University
Chicago, Illinois, United States
Hereditary Neurological Disease Center, Inc
Wichita, Kansas, United States
Albany Medical College
Albany, New York, United States
Columbia University
New York, New York, United States
Duke University
Durham, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Monash University/Bethlehem Hospital
Melbourne, , Australia
Westmead Hospital
Sydney, , Australia
Center for Movement Disorders
Markham, Ontario, Canada
Department of Neuropsychiatry
Edgbaston, Birmingham, United Kingdom
Plymouth Hospitals NHS Trust
Derriford, Plymouth, United Kingdom
University Hospital of Wales Cardiff
Cardiff, Wales, United Kingdom
Cambridge Center for Brain Repair
Cambridge, , United Kingdom
University of Manchester
Manchester, , United Kingdom
Countries
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Related Links
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Link to funding agency for the CAB Beta study
Other Identifiers
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CAB Beta
Identifier Type: -
Identifier Source: org_study_id