Cognitive Assessment Battery (CAB) Beta Study

This study has been completed.
Sponsor:
Collaborator:
Monash University
Information provided by (Responsible Party):
CHDI Foundation, Inc.
ClinicalTrials.gov Identifier:
NCT01290861
First received: February 4, 2011
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

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.


Condition
Huntington's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognitive Assessment Battery (CAB)Beta Study

Resource links provided by NLM:


Further study details as provided by CHDI Foundation, Inc.:

Enrollment: 255
Study Start Date: February 2011
Groups/Cohorts
pre-manifest HD
early manifest HD
healthy controls

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.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

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

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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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290861

Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92037
University of California, Los Angeles
Los Angeles, California, United States, 90095
University of California, San Francisco
San Francisco, California, United States, 94117
United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
United States, Illinois
Rush University
Chicago, Illinois, United States, 60612
United States, Kansas
Hereditary Neurological Disease Center, Inc
Wichita, Kansas, United States, 67206
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Columbia University
New York, New York, United States, 10032
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Australia
Monash University/Bethlehem Hospital
Melbourne, Australia
Westmead Hospital
Sydney, Australia
Canada, Ontario
Center for Movement Disorders
Markham, Ontario, Canada, L6B 1C9
United Kingdom
Department of Neuropsychiatry
Edgbaston, Birmingham, United Kingdom, B15 2FG
Plymouth Hospitals NHS Trust
Derriford, Plymouth, United Kingdom, PL6 8BX
University Hospital of Wales Cardiff
Cardiff, Wales, United Kingdom
Cambridge Center for Brain Repair
Cambridge, United Kingdom, CB2 OPY
University of Manchester
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
CHDI Foundation, Inc.
Monash University
Investigators
Principal Investigator: Beth Borowsky, Ph.D. CHDI Foundation, Inc.
Principal Investigator: Julie C Stout, Ph.D. Monash University
  More Information

Additional Information:
No publications provided

Responsible Party: CHDI Foundation, Inc.
ClinicalTrials.gov Identifier: NCT01290861     History of Changes
Other Study ID Numbers: CAB Beta
Study First Received: February 4, 2011
Last Updated: August 2, 2012
Health Authority: Australia: Human Research Ethics Committee
United Kingdom: National Health Service
United States: Institutional Review Board

Keywords provided by CHDI Foundation, Inc.:
Huntington's Disease
Cognitive Battery
Cognitive Testing
Cognition
pre-manifest Huntington's Disease

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014