Sensitivity of Project: EVO Monitor Cognitive Measurements to Pharmacological Agents

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy

In brief

This is a study in adults to assess the sensitivity of Project: EVO Monitor cognitive measurements to two short-acting cognitively active pharmacological agents. The participants will receive a placebo, and two pharmacological agents in a randomized order for three in-clinic study days. During each study day in the clinic, the participants will use Project: EVO Monitor and another cognitive task through the day.

Key facts

Study ID

NCT02822937

Run by

Akili Interactive Labs, Inc.

People needed

18

Starts

2016-07-01

Expected to finish

2016-11-01

Last updated by the study team

2016-11-07

Who can join

Age: 40 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 40-55 at the time of informed consent
• Ability to follow written and verbal instructions (English).
• Weight between 140 lbs and 240 lbs.
• Male and female (Gender-matched).
• Ability to comply with all the testing and requirements.

You may not qualify if…

• Known adverse reaction to study medications.
• Known non-response or paradoxical response to study medications.
• Current, controlled (requiring a restricted medication) or uncontrolled, self-reported psychiatric diagnosis with significant symptoms such as post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or anxiety disorder, conduct disorder, attention deficit disorder, autism spectrum disorder, or other symptomatic manifestations that in the opinion of the Investigator that may confound study data/assessments.
• Current self-reported community diagnosis of cognitive ailments such as dementia, Alzheimer's disease, stroke, traumatic brain injury, or other diseases that in the opinion of the Investigator that may confound study data/assessments.
• Current diagnosis of severe learning disorder, dyslexia, or dyscalculia.
• Current subjective complaints of inattention or memory loss.
• Currently undergoing psychotherapy, behavioral therapy, or occupational therapy.
• Current use of psychotropic medication, prescription or otherwise.
• Motor condition that prevents game playing, as reported by parent or observed by investigator.
• Impaired visual acuity, as defined by difficulty reading the informed consent even with corrective lenses.
• Lifetime history of suspected substance abuse or dependence.
• Current use (defined as within the last 30 days) of products with nicotine, e.g. cigarettes, chewing tobacco, e-cigarettes, nicotine patch, and nicotine gum.
• History of seizures (exclusive of febrile seizures), a tic disorder, significant tics, a current diagnosis of Tourette's Disorder.
• Taken part in a clinical trial within 30 days prior to screening.
• Diagnosis of or patient-reported color blindness.
• Regular use of psychoactive drugs that in the opinion of the Investigator may confound study data/assessments.
• Pregnancy.
• Currently nursing or breastfeeding.
• Resting heart rate > 100 beats/min.
• Systolic blood pressure > 150 mm/Hg.
• History of cardiac abnormalities.
• History of glaucoma.
• Current use of monoamine oxidase inhibitors, HIV protease inhibitors, ranitidine, isoniazid, ketoconazole, itraconazole, nefazodone and other azole-type antifungal agents or any other drugs that are contra-indicated for use with study medications.
• Any other medical condition that in the opinion of the investigator may confound study data/assessments.
• Any other medical condition that in the opinion of the investigator prohibits the administration of any study medication.

Where it is running

• Clinical Trials of Texas — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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