Status:
COMPLETED
Allopregnanolone for Mild Cognitive Impairment Due to Alzheimer's Disease or Mild AD
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Mild Cognitive Impairment
Alzheimer Disease
Eligibility:
All Genders
55+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of allopregnanolone, a naturally occurring brain steroid, in mild cognitive impairment and early Alzheimer's disease participants. ...
Detailed Description
1\) Each dose group will be comprised of 8 participants (6 randomized to allopregnanolone; 2 randomized to placebo) administered one dose of allopregnanolone or placebo once per week for 12 weeks. A h...
Eligibility Criteria
Inclusion
- Men or postmenopausal women
- 55 years of age or older
- Diagnosis of MCI due to AD or mild AD
- MMSE \> 20 at screen
- Capacity to provide informed consent
- Residing in the community with a caregiver able to accompany the patient to clinic visits
- No medical contraindications to participation
- Willingness to comply with study procedures
Exclusion
- Use of benzodiazepines, sedative/hypnotics, anticonvulsants, antipsychotics, and other drugs that might interact with the GABA-A receptor complex
- Seizure disorder, history of stroke, focal brain lesion, traumatic brain injury, substance abuse, malignancy
- Clinically significant laboratory or ECG abnormality
- MRI indicative of any other significant abnormality, including but not limited to evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions
- Any condition that would contraindicate an MRI such as the presence of metallic objects in the eyes, skin, heart, or body
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02221622
Start Date
August 1 2014
End Date
February 1 2018
Last Update
July 5 2019
Active Locations (1)
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1
University of Southern California - Alzheimer Disease Research Center - Healthcare Consultation Center II
Los Angeles, California, United States, 90033