Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01290861




Registration number
NCT01290861
Ethics application status
Date submitted
4/02/2011
Date registered
7/02/2011
Date last updated
3/08/2012

Titles & IDs
Public title
Cognitive Assessment Battery (CAB) Beta Study
Scientific title
Cognitive Assessment Battery (CAB)Beta Study
Secondary ID [1] 0 0
CAB Beta
Universal Trial Number (UTN)
Trial acronym
CAB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Huntington's Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
pre-manifest HD -

early manifest HD -

healthy controls -

Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
.

1. For early HD group, subjects eligible are persons who meet the following 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

-
Minimum age
25 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Current use of investigational drugs or participation in a clinical drug trial (unless approved by the CAB Beta study principal investigator or sponsor);
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
255
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash University/Bethlehem Hospital - Melbourne
Recruitment hospital [2] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Birmingham
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Plymouth
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Wales
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Cambridge
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Other
Name
CHDI Foundation, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Beth Borowsky, Ph.D.
Address 0 0
CHDI Foundation, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01290861