Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-27 @ 10:04 PM
Study NCT ID:
NCT01290861
Status:
COMPLETED
Last Update Posted:
2012-08-03
First Post:
2011-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Assessment Battery (CAB) Beta Study
Sponsor:
CHDI Foundation, Inc.
Organization:
Study Overview
Official Title:
Cognitive Assessment Battery (CAB)Beta Study
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAB
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: