Allopregnanolone for Mild Cognitive Impairment Due to Alzheimer's Disease or Mild AD

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

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. The primary goal is to determine the maximally tolerated dose.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Collaborator: National Institute on Aging (NIA)
• Treatments: Pharmaceutical Solutions; Pregnanolone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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