← Trials/Trial dossier/NCT02221622

Allo

CompletedPhase 1

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

Allopregnanolone Regenerative Therapeutic for MCI/AD: Dose Finding Phase 1

Lead sponsor

University of Southern California

Asset

Allopregnanolone

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•MCI due to AD•MMSE ≥20•Study partner/caregiver required

Primary endpoints

•Safety profile•Tolerability - Maximum tolerated dose (MTD)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Nih1UF1AG046148

Org study IDAlloPhase1

NCT IDNCT02221622

Timeline

Milestones

Study start2014-08 (month precision)

Study first posted2014-08-20estimated

Primary completion2018-02actual (month precision)

Study completion2018-02actual (month precision)

Last update posted2019-07-05actual

Assets

Drug assets

Allopregnanolone

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Global cognition

Amyloid biomarkers

Neuroimaging

Global cognition

1 endpoint

Secondary/protocol endpoint

Cognitive tests (ADAS-Cog; MMSE/MoCA; ADCS-CGIC; CogState)

Time frame:Baseline to Week 13

ADAS-Cog

descriptive

Amyloid biomarkers

1 endpoint

Primary/protocol endpoint

Safety profile: ARIA

Time frame:From Baseline to week 13

threshold achievement, improvement

Neuroimaging

1 endpoint

Secondary/protocol endpoint

Brain MRI volumetrics

Time frame:Baseline and Week 13

descriptive

Safety / tolerability / PK

9 endpoints

Primary/protocol endpoint

Safety profile: Adverse events

Time frame:From Baseline to week 16

event count, event

Primary/protocol endpoint

Safety profile: Clinical laboratory measurements

Time frame:From Baseline to week 13

threshold achievement, event

Primary/protocol endpoint

Safety profile: Physical and neurological examination

Time frame:From Baseline to week 16

threshold achievement, event

Primary/protocol endpoint

Tolerability - Maximum tolerated dose (MTD)

Time frame:From Baseline to week 12

descriptive

Secondary/protocol endpoint

Pharmacokinetic profile after single and multiple doses: Maximum Concentration (Cmax)

Time frame:Weeks: 1 and 12

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic profile after single and multiple doses: time attain to Cmax (Tmax)

Time frame:Weeks: 1 and 12

time to event, event

Secondary/protocol endpoint

Pharmacokinetic profile after single and multiple doses: Area under the curve (AUC)

Time frame:Weeks: 1 and 12

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic profile after single and multiple doses: Drug Clearance (CL)

Time frame:Weeks: 1 and 12

descriptive

Secondary/protocol endpoint

Pharmacokinetic profile after single and multiple doses: apparent volume of distribution at steady state (Vss)

Time frame:Weeks: 1 and 12

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Hernandez GD, Solinsky CM, Mack WJ, Kono N, Rodgers KE, Wu CY, Mollo AR, Lopez CM, Pawluczyk S, Bauer G, Matthews D, Shi Y, Law M, Rogawski MA, Schneider LS, Brinton RD. Safety, tolerability, and pharmacokinetics of allopregnanolone as a regenerative therapeutic for Alzheimer's disease: A single and multiple ascending dose phase 1b/2a clinical trial. Alzheimers Dement (N Y). 2020 Dec 16;6(1):e12107. doi: 10.1002/trc2.12107. eCollection 2020.
PMID33344752via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.