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Allo-IM

TerminatedPhase 1

Allopregnanolone Regenerative Therapeutic for Early Alzheimer's Disease: Intramuscular Study

Allopregnanolone Regenerative Therapeutic for Early Alzheimer's Disease: IV to IM Bridging Study

Lead sponsor

University of Arizona

Asset

Allopregnanolone

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•MCI due to AD•MMSE ≥20•MRI contraindications excluded

Primary endpoints

•Safety - Adverse events•Safety - clinical laboratory measures•Safety - clinical assessment

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

Org study IDAlloPhase1-IM

NCT IDNCT03748303

Timeline

Milestones

Study first posted2018-11-20actual

Study start2019-10-01actual

Primary completion2022-12-21actual

Study completion2022-12-21actual

Last update posted2026-03-13actual

Assets

Drug assets

Allopregnanolone

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Provision of signed and dated informed consent form

•Stated willingness to comply with all study procedures and availability for the duration of the study

•Men or postmenopausal women, aged 55 years or older

•Diagnosis of MCI due to AD or mild AD

•In good general health as evidenced by medical history and with no medical contraindications to participation

•MMSE > 20 at screen

•Caregiver willing and capable to accompany the patient to clinic visits

Exclusion criteria

•Daily 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 obtained at screening visit.

•MRI indicative of significant abnormality, including but not limited to evidence of a single prior hemorrhage or infarct >1 cm3, multiple lacunar infarcts (>1) or evidence of a single prior infarct >1cm3, evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions (e.g. abscess or tumor).

•Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI.

•Is currently enrolled in a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research or observational study judged not to be scientifically or medically compatible with this study.

Endpoints (21)

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

Behavior / neuropsychiatric

Other (unclassified)

Global cognition

Function / daily living

Neuroimaging

Fluid / digital biomarkers

Caregiver / quality of life

Other clinical outcomes

Global cognition

2 endpoints

Other/protocol endpoint

Mini-Mental State Exam (MMSE)

Time frame:Baseline to visit 16 (14 weeks)

Mini-Mental State Examination (MMSE)

descriptive

Other/protocol endpoint

Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)

Time frame:Baseline to visit 16 (14 weeks)

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Function / daily living

1 endpoint

Other/protocol endpoint

Activities of daily living

Time frame:Baseline to visit 16 (14 weeks)

descriptive

Behavior / neuropsychiatric

3 endpoints

Other/protocol endpoint

Actigraphy sleep assessment - Total sleep time

Time frame:Screen to visit 16 (16 weeks)

time to event, event

Other/protocol endpoint

Actigraphy sleep assessment - Wake after sleep onset

Time frame:Screen to visit 16 (16 weeks)

descriptive

Other/protocol endpoint

Actigraphy sleep assessment - Sleep efficiency

Time frame:Screen to visit 16 (16 weeks)

descriptive

Neuroimaging

1 endpoint

Other/protocol endpoint

MRI brain volumes

Time frame:Baseline to visit 16 (14 weeks)

ratio, descriptive

Fluid / digital biomarkers

1 endpoint

Other/protocol endpoint

Physical activity

Time frame:Screen to visit 16 (16 weeks)

descriptive

Caregiver / quality of life

1 endpoint

Other/protocol endpoint

Caregiver burden survey

Time frame:Baseline to visit 16 (14 weeks)

descriptive

Safety / tolerability / PK

8 endpoints

Primary/protocol endpoint

Safety - Adverse events

Time frame:From baseline to visit 16 (14 weeks)

event count, event

Primary/protocol endpoint

Safety - clinical laboratory measures

Time frame:From Baseline to visit 16 (14 weeks)

threshold achievement, event

Primary/protocol endpoint

Safety - clinical assessment

Time frame:From Baseline to visit 16 (14 weeks)

threshold achievement, event

Secondary/protocol endpoint

Pharmacokinetic parameter - Cmax

Time frame:Visits 3 - 6 (up to 4 weeks)

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic parameter - AUC

Time frame:Visits 3 - 6 (up to 4 weeks)

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic parameter - Tmax

Time frame:Visits 3 - 6 (up to 4 weeks)

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic parameter - Clearance

Time frame:Visits 3 - 6 (up to 4 weeks)

descriptive

Secondary/protocol endpoint

Pharmacokinetic parameter - Volume of distribution

Time frame:Visits 3 - 6 (up to 4 weeks)

descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Satisfaction and feasibility of home nurse survey

Time frame:Visits 8-9 and 11-15 (up to 8 weeks)

descriptive

Other (unclassified)

3 endpoints

Other/protocol endpoint/low confidence

Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associates Learning (PAL)

Time frame:Baseline to visit 16 (14 weeks)

descriptive

Other/protocol endpoint/low confidence

Alzheimer's Disease Assessment Scale Cognitive Subscale 14 (ADAS-Cog14)

Time frame:Baseline to visit 16 (14 weeks)

ADAS-Cog

change from baseline, improvement

Other/protocol endpoint/low confidence

Cogstate Alzheimer's battery

Time frame:Baseline to visit 16 (14 weeks)

descriptive

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.