Allopregnanolone Regenerative Therapeutic for Early Alzheimer's Disease: Intramuscular Study
NCT03748303 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2026-03-13
Summary
The purpose of this study is to identifying the intramuscular dose equivalent to the 4mg intravenous dose and assess its safety and tolerability as a weekly injection.
Conditions
- Alzheimer Dementia
Interventions
- DRUG
-
Allopregnanolone
Administration of weekly IM injections of Allopregnanolone.
Sponsors & Collaborators
-
University of Southern California
collaborator OTHER - collaborator OTHER
-
University of Arizona
lead OTHER
Principal Investigators
-
Roberta D Brinton, PhD · University of Arizona
-
Lon S Schneider, MD, MS · University of Southern California
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-01
- Primary Completion
- 2022-12-21
- Completion
- 2022-12-21
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
An Open-Label Crenezumab Study in Participants With Alzheimer's Disease
NCT03491150 ·Status: TERMINATED ·Phase: PHASE3
-
Allopregnanolone in Chronic Complex Traumatic Brain Injury
NCT04003285 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Efficacy, Safety, & Tolerability of AZD3480 Patients With Mild to Moderate Dementia of the Alzheimer's Type (AD)
NCT01466088 ·Status: COMPLETED ·Phase: PHASE2
-
Allopregnanolone for the Treatment of Traumatic Brain Injury
NCT01673828 ·Status: COMPLETED ·Phase: PHASE2
-
Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease
NCT04639050 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.
NCT00531804 ·Status: COMPLETED ·Phase: PHASE1
-
Single Dose Escalation Study of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease
NCT00733642 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease
NCT02080364 ·Status: TERMINATED ·Phase: PHASE3
-
A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD
NCT05231785 ·Status: RECRUITING ·Phase: PHASE1
-
Clinical Trial to Determine Tolerable Dosis of Vorinostat in Patients With Mild Alzheimer Disease
NCT03056495 ·Status: TERMINATED ·Phase: PHASE1
-
A Multiple Ascending Dose Study in Healthy Volunteers and Patients With Alzheimer's Disease
NCT05804383 ·Status: COMPLETED ·Phase: PHASE1
-
ELND005 in Patients With Mild to Moderate Alzheimer's Disease
NCT00568776 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability and Efficacy Study to Evaluate Subjects With Mild Cognitive Impairment
NCT00422981 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of ABT-126 in Subjects With Alzheimer's Disease
NCT01482845 ·Status: COMPLETED ·Phase: PHASE1
-
WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease
NCT05032482 ·Status: WITHDRAWN ·Phase: NA
-
A Study to Assess the Safety of GRF6019 Infusions in Subjects With Severe Alzheimer's Disease
NCT03765762 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD
NCT02624778 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease
NCT00884507 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease
NCT03131453 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease
NCT00722046 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients
NCT00795418 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety, Tolerability, and Blood Levels of ACU193 in Participants With MCI or Mild AD
NCT04931459 ·Status: COMPLETED ·Phase: PHASE1
-
To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
NCT01023685 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Evaluating the Efficacy and Safety of Crenezumab Versus Placebo in Participants With Prodromal to Mild Alzheimer's Disease (AD).
NCT02670083 ·Status: TERMINATED ·Phase: PHASE3
-
A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) Mutation
NCT03636204 ·Status: COMPLETED ·Phase: PHASE1