Cognitive Assessment Battery (CAB) Beta Study

Completed

Conditions studied: Huntington's Disease

In brief

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.

Key facts

Study ID

NCT01290861

Run by

CHDI Foundation, Inc.

People needed

255

Starts

2011-02-01

Last updated by the study team

2012-08-03

Who can join

Age: 25 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.