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

Completed · Phase 1 · Has a placebo group

Conditions studied: Mild Cognitive Impairment, Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT02221622

Run by

University of Southern California

People needed

24

Starts

2014-08-01

Expected to finish

2018-02-01

Last updated by the study team

2019-07-05

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Southern California - Alzheimer Disease Research Center - Healthcare Consultation Center II — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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