Multi-Center Study of Sensory Stimulation to Improve Brain Function
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease, Cognitive Studies, Cognitive Studies, Cognitive Studies, Cognitive Studies, Cognitive Studies, Cognitive Studies, Neurology |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 55 - Any |
| Updated: | 3/1/2019 |
| Start Date: | April 24, 2018 |
| End Date: | October 2019 |
| Contact: | Evan R Hempel |
| Email: | info@cognitotx.com |
| Phone: | (857)201-5088 |
Multi-Center Study of Sensory Stimulation to Improve Brain Function (Overture Study)
The Overture Study is a randomized, controlled, single-blind multi-center clinical trial
using the GammaSense Stimulation system to study safety, tolerability, and efficacy in people
with mild to moderate cognitive impairment.
using the GammaSense Stimulation system to study safety, tolerability, and efficacy in people
with mild to moderate cognitive impairment.
The Overture Study (CA-0005) is a Phase I/II randomized, controlled, single-blind
multi-center clinical trial using the GammaSense Stimulation device to study safety,
adherence rates and efficacy in subjects with mild to moderate cognitive impairment (MMSE
14-26) who are age 55 and older.
Subjects who pass screening will be randomized (ratio 2:1 Treatment to Control). Subjects and
their caregivers will be blinded to their randomization group, as will key raters at each
site. The device will be used for 60 minutes daily during the 6-month therapy phase, followed
by a one month safety follow-up visit.
multi-center clinical trial using the GammaSense Stimulation device to study safety,
adherence rates and efficacy in subjects with mild to moderate cognitive impairment (MMSE
14-26) who are age 55 and older.
Subjects who pass screening will be randomized (ratio 2:1 Treatment to Control). Subjects and
their caregivers will be blinded to their randomization group, as will key raters at each
site. The device will be used for 60 minutes daily during the 6-month therapy phase, followed
by a one month safety follow-up visit.
Inclusion Criteria:
- >= 55 Years old
- MMSE 14-26
- Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD
- Participation of a caregiver
Exclusion Criteria:
- Profound hearing or visual impairment
- Seizure Disorder
- Use of memantine (Namenda or Namzaric)
- Implantable devices (non-MR compatible)
We found this trial at
6
sites
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