Huntington's DiseaseCABNCT01290861
Cognitive Assessment Battery (CAB) Beta Study
An observational study of Huntington's Disease, run by CHDI Foundation, Inc. at 20 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington's Disease
- How many people
- 255 participants
- Where
- 20 sitesin 4 countries
- Study dates
- Feb 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- 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
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- 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;
- Are ambulatory and do not require skilled nursing care;
- Have not had cognitive testing for 2 or more months prior to the participation in cognitive testing for the current study;
- Will not have cognitive testing for other purposes during the course of the study; and,
- 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
- -
Who cannot join
- 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;
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- 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
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
United States12 sites
Albany Medical College
Albany, New York, 12208
Rush University
Chicago, Illinois, 60612
The Ohio State University
Columbus, Ohio, 43210
Duke University
Durham, North Carolina, 27705
University of California, San Diego
La Jolla, California, 92037
University of California, Los Angeles
Los Angeles, California, 90095
Columbia University
New York, New York, 10032
Oregon Health and Science University
Portland, Oregon, 97239
University of California, San Francisco
San Francisco, California, 94117
University of South Florida
Tampa, Florida, 33612
Hereditary Neurological Disease Center, Inc
Wichita, Kansas, 67206
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
United Kingdom5 sites
Cambridge Center for Brain Repair
Cambridge, CB2 OPY
University Hospital of Wales Cardiff
Cardiff, Wales
Plymouth Hospitals NHS Trust
Derriford, Plymouth, PL6 8BX
Department of Neuropsychiatry
Edgbaston, Birmingham, B15 2FG
University of Manchester
Manchester, M13 9WL
Australia2 sites
Monash University/Bethlehem Hospital
Melbourne
Westmead Hospital
Sydney
About this study
Official title: Cognitive Assessment Battery (CAB)Beta Study
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.
Read the detailed description
Huntington's disease (HD) is an autosomal dominant genetic disease which typically manifests beginning in adulthood in the form of movement symptoms, cognitive decline, and psychiatric changes. The proposed research is undertaken in collaboration with CHDI Foundation, Inc., a not for profit organization dedicated to finding treatments for HD. CHDI's goal is to develop or help to develop both symptomatic and disease modifying treatments for HD. To enable future therapeutic trials, CHDI has sponsored several prospective, longitudinal, observational biomarker studies of pre-manifest and early HD with the goal of determining which combination of measures is the most sensitive for detecting changes over the natural progression of pre-manifest and early HD. These and other studies have demonstrated a progressive decline in cognitive function in patients with the huntingtin gene mutation beginning in the pre-manifest period and progressing throughout the course of the disease. These findings support the use of cognitive measures as endpoints in future therapeutic clinical trials. CHDI is committed to the development of a cognitive assessment battery for use in HD therapeutic trials.
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
- Huntington's Disease
- Keywords
- Huntington's Disease, Cognitive Battery, Cognitive Testing, Cognition, pre-manifest Huntington's Disease
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pre-manifest HD | Not described | |
| early manifest HD | Not described | |
| healthy controls | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHDI Foundation, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University
- Responsible party
- Sponsor
- Investigators
- Beth Borowsky, Ph.D., Principal investigator, CHDI Foundation, Inc.Julie C Stout, Ph.D., Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290861
- Sponsor's protocol ID
- CAB Beta
- Acronym
- CAB
- Status last verified
- Aug 2012
- First submitted
- 4 Feb 2011
- Last updated
- 3 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Assessment Battery (CAB)Beta Study
- ClinicalTrials.gov ID
- NCT01290861
- Acronym / sponsor ID
- CAB / CAB Beta
- Conditions
- Huntington's Disease
- Keywords
- Huntington's Disease, Cognitive Battery, Cognitive Testing, Cognition, pre-manifest Huntington's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- CHDI Foundation, Inc.University, hospital or other
- Collaborators
- Monash University
- Study start
- Feb 2011
- First posted
- 7 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Huntington's disease (HD) is an autosomal dominant genetic disease which typically manifests beginning in adulthood in the form of movement symptoms, cognitive decline, and psychiatric changes. The proposed research is undertaken in collaboration with CHDI Foundation, Inc., a not for profit organization dedicated to finding treatments for HD. CHDI's goal is to develop or help to develop both symptomatic and disease modifying treatments for HD. To enable future therapeutic trials, CHDI has sponsored several prospective, longitudinal, observational biomarker studies of pre-manifest and early HD with the goal of determining which combination of measures is the most sensitive for detecting changes over the natural progression of pre-manifest and early HD. These and other studies have demonstrated a progressive decline in cognitive function in patients with the huntingtin gene mutation beginning in the pre-manifest period and progressing throughout the course of the disease. These findings support the use of cognitive measures as endpoints in future therapeutic clinical trials. CHDI is committed to the development of a cognitive assessment battery for use in HD therapeutic trials.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pre-manifest HD | – | – |
| early manifest HD | – | – |
| healthy controls | – | – |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (25 listed)
- For early HD group, subjects eligible are persons who meet the following criteria:
- For the late pre-manifest HD group, subjects eligible are persons who meet the following criteria:
- For the healthy control group, subjects eligible are persons who meet the following criteria:
- For all groups, subjects eligible are persons who meet the following criteria:
- Education inclusion criterion definition based on ISCED ISCED level 2: Completion of lower secondary general
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2012.
- Link to funding agency for the CAB Beta studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Borowsky, Ph.D. principal investigator
CHDI Foundation, Inc.
Julie C Stout, Ph.D. principal investigator
Monash University
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington's Disease, run by CHDI Foundation, Inc. at 20 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, United Kingdom, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2012.