Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-24 @ 12:47 PM
NCT ID:
NCT01290861
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.
Study:
NCT01290861
Study Brief:
Protocol Section:
NCT01290861