Cognitive Remediation for HIV-associated Neurocognitive Dysfunction
Status: | Completed |
---|---|
Conditions: | Cognitive Studies |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 25 - 60 |
Updated: | 11/24/2016 |
Start Date: | December 2015 |
End Date: | November 2016 |
Plasticity-based Adaptive Cognitive Remediation (PACR) for HIV-associated Neurocognitive Dysfunction
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.
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.
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)
We found this trial at
1
site
San Francisco, California 94104
Principal Investigator: Thomas Van Vleet, Ph.D.
Phone: 415-539-3130
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