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Cognitive Remediation for HIV-associated Neurocognitive Dysfunction

NCT ID: NCT02671526

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV-associated Neurocognitive Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Computerized Plasticity-based Adaptive Cognitive Training

Group Type EXPERIMENTAL

Computerized plasticity-based adaptive cognitive training

Intervention Type OTHER

Interventions

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Computerized plasticity-based adaptive cognitive training

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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)
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Posit Science Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Van Vleet, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Posit Science Corporation

Locations

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Posit Science Corporation

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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PSC-1005-14

Identifier Type: -

Identifier Source: org_study_id