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Cognitive Remediation for HIV-associated Neurocognitive Dysfunction (HAND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671526
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
Posit Science Corporation

Brief Summary:
This study is a validation study to document the acceptability of the revised Plasticity-based Adaptive Cognitive Remediation (PACR) program to patients with HIV-associated Neurocognitive Dysfunction (HAND). The primary objective of this study is to evaluate the effects of the revised PACR program on the cognitive abilities (e.g., attention, executive function), functional status and quality of life of individuals diagnosed with HAND. The secondary objective of the study is to collect relevant data to support a pre-investigational device exemption (IDE) submission to the FDA required before the pivotal randomized, controlled trial planned for Phase II.

Condition or disease Intervention/treatment Phase
HIV-associated Neurocognitive Dysfunction Other: Computerized plasticity-based adaptive cognitive training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Plasticity-based Adaptive Cognitive Remediation (PACR) for HIV-associated Neurocognitive Dysfunction
Study Start Date : December 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Computerized Plasticity-based Adaptive Cognitive Training Other: Computerized plasticity-based adaptive cognitive training



Primary Outcome Measures :
  1. Computerized Exercise-based Assessment [ Time Frame: 3 months ]
    The primary outcome measure is the useful field of view; change on this measure suggests underlying neural change, and has been shown to predict overall cognitive change. The exercise-based measure serves as a positive control for task learning. The investigators anticipate improvements in this assessment because participants have directly practiced these tasks, as well as tasks within related cognitive domains. The data are relevant because individuals failing to make progress on this assessment may represent a subpopulation not treatable with this program, and individuals making strong progress may represent a subpopulation particularly amenable to treatment with this program. This assessment will be performed on the first day of program use, approximately halfway through program use, and the last day of program use. All participants will access this assessment via Internet portal and study team member may access results via clinician portal.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Participant is between 25-60 years of age
  2. Participant is HIV positive
  3. Participant has diagnosis of HIV-associated neurocognitive disorder (HAND), Mild Neurocognitive Disorder (MND) and HIV associated dementia (HAD)
  4. Participant is fluent in English
  5. Participant is able to use an iPad and have access to wireless internet connection
  6. Participant does not have a history of other conditions (other that from HAND), including mental illness, cancer, or other neurological conditions (multiple sclerosis, seizure disorder)
  7. Participant is not enrolled in another research study
  8. Participant does not have current or significant past history of substance abuse
  9. Participant does not have severe depression or other chronic psychiatric disorder (eg. Schizophrenia or Bipolar Disorder)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671526


Locations
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United States, California
Posit Science Corporation
San Francisco, California, United States, 94108
Sponsors and Collaborators
Posit Science Corporation
Investigators
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Principal Investigator: Thomas Van Vleet, Ph.D. Posit Science Corporation
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Responsible Party: Posit Science Corporation
ClinicalTrials.gov Identifier: NCT02671526    
Other Study ID Numbers: PSC-1005-14
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders