Cognitive Remediation for HIV-associated Neurocognitive Dysfunction

NCT02671526 | Completed DMC

• 1 other identifier: PSC-1005-14
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-associated Neurocognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Computerized Exercise-based Assessment

  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.

  3 months

Study Arms (1)

Computerized Plasticity-based Adaptive Cognitive Training

EXPERIMENTAL

Other: Computerized plasticity-based adaptive cognitive training

Interventions

Computerized plasticity-based adaptive cognitive training OTHER

Computerized Plasticity-based Adaptive Cognitive Training

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Posit Science Corporation: lead

Study Sites (1)

Posit Science Corporation

San Francisco, California, 94108, United States

Location

Study Officials

• Thomas Van Vleet, Ph.D.

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 2, 2016
• Study Start: December 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 23, 2016

Record last verified: 2016-11

Locations

US (1)