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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2018-02-28

Brief Summary

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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.

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Detailed Description

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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 higher dose will be administered to the next group of participants when the lower dose is shown to be safe and tolerable. 2) Pharmacokinetic analyses will be conducted on blood samples taken from participants at the beginning and end of the trial. 3) The trial will assess safety including via MRI brain imaging.

Conditions

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Mild Cognitive Impairment Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Allopregnanolone 2 mg

Drug: Allopregnanolone injection (intravenous solution) once per week for 12 weeks

Group Type EXPERIMENTAL

Allopregnanolone injection (intravenous solution)

Intervention Type DRUG

Allopregnanolone intravenous infusion

Allopregnanolone 4 mg

Drug: Allopregnanolone injection (intravenous solution) once per week for 12 weeks

Group Type EXPERIMENTAL

Allopregnanolone injection (intravenous solution)

Intervention Type DRUG

Allopregnanolone intravenous infusion

Allopregnanolone 6-18 mg

Drug: Allopregnanolone injection (intravenous solution) once per week for 12 weeks

Group Type EXPERIMENTAL

Allopregnanolone injection (intravenous solution)

Intervention Type DRUG

Allopregnanolone intravenous infusion

Placebo

Drug: Placebo injection (intravenous solution) once per week for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo injection (intravenous solution)

Intervention Type DRUG

Placebo intravenous infusion

Interventions

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Allopregnanolone injection (intravenous solution)

Allopregnanolone intravenous infusion

Intervention Type DRUG

Placebo injection (intravenous solution)

Placebo intravenous infusion

Intervention Type DRUG

Other Intervention Names

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3α,5α-tetrahydroprogesterone 3α-hydroxy-5α-pregnan-20-one

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No