Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease
NCT ID: NCT04838301
Last Updated: 2025-05-11
Study Results
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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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2023-08-15
2026-04-30
Brief Summary
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Detailed Description
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After a 2-4-week screening period, participants will be randomized to 4 mg Allo (administered intravenously over 30 minutes, once per week, in clinic) or matching placebo, 1:1 allocation, for a period of 12 months. After 12 months, all participants in the placebo group will be crossed-over to receive Allo for the remainder of the study (6 month open-label phase). Brain imaging to evaluate the primary endpoint will be conducted at baseline, 6 and 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Allo group
Allopregnanolone 4mg IV 30-minute infusion once per week for 12 months.
Allopregnanolone
Allopregnanolone 4mg IV via 30-minute infusion, once per week.
Control group
Placebo (normal saline) IV 30-minute infusion once per week for 12 months.
Placebo
Normal saline solution IV via 30-minute infusion, once per week
Interventions
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Allopregnanolone
Allopregnanolone 4mg IV via 30-minute infusion, once per week.
Placebo
Normal saline solution IV via 30-minute infusion, once per week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 55 to 80 years old
* Meets NIA-AA criteria for probable AD dementia
* MMSE of 20-26
* APOE ε4 positive
* Geriatric Depression Scale short form (GDS-S) score of ≤ 6
* No medical contraindications to participation
* Capacity to provide informed consent at screening
Exclusion Criteria
* Use of benzodiazepines, anticonvulsants, antipsychotics, or other drugs that might interact with the GABA-A receptor complex
* History of stroke with a modified Hachinski Ischemic Scale score \>4
* History of seizure disorder, focal brain lesion, traumatic brain injury
* History within the last 5 years of a primary or recurrent malignant disease
* Unstable or clinically significant cardiovascular, kidney or liver disease
* MRI indicative of any other significant abnormality, including but not limited to one or more significant ARIA-E or macro-hemorrhage findings, or multiple microhemorrhages (\>8), or Fazekas score of 3; encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions
* Any conditions that would contraindicate MRI studies.
55 Years
80 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Syneos Health
OTHER
University of Southern California
OTHER
ADM Diagnostics
UNKNOWN
University of Arizona
OTHER
Responsible Party
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Roberta Brinton
Director, Center for Innovation in Brain Science; Professor, Departments of Pharmacology and Neurology
Principal Investigators
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Roberta D Brinton, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Lon Schneider, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Gerson D Hernandez, MD, MPH
Role: STUDY_DIRECTOR
University of Arizona
Locations
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Perseverance Research Center
Scottsdale, Arizona, United States
ATP Clinical Research
Costa Mesa, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Optimus U Corporation
Miami, Florida, United States
Miami Jewish Health
Miami, Florida, United States
Combined Research
Orlando, Florida, United States
Conquest Research
Winter Park, Florida, United States
MedVadis Research
Waltham, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Nicole Hank, PhD
Role: primary
Bobby Shih
Role: primary
Caitlyn Villanueva
Role: backup
Emily Watson
Role: primary
Rebecca Bonar
Role: backup
Yaneicy Gonazalez Rojas, MD
Role: primary
Mariolga Aymat
Role: primary
Alexander Gomez
Role: backup
Adrian Delgado
Role: primary
Yenilady Estevez
Role: backup
Melissa O'Neill
Role: primary
Rathod Meera
Role: backup
Donald Counihan
Role: primary
Jessica O'Brien
Role: backup
References
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Raikes AC, Hernandez GD, Matthews DC, Lukic AS, Law M, Shi Y, Schneider LS, Brinton RD. Exploratory imaging outcomes of a phase 1b/2a clinical trial of allopregnanolone as a regenerative therapeutic for Alzheimer's disease: Structural effects and functional connectivity outcomes. Alzheimers Dement (N Y). 2022 Mar 14;8(1):e12258. doi: 10.1002/trc2.12258. eCollection 2022.
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.
Brinton RD. Neurosteroids as regenerative agents in the brain: therapeutic implications. Nat Rev Endocrinol. 2013 Apr;9(4):241-50. doi: 10.1038/nrendo.2013.31. Epub 2013 Feb 26.
Brinton RD, Wang JM. Therapeutic potential of neurogenesis for prevention and recovery from Alzheimer's disease: allopregnanolone as a proof of concept neurogenic agent. Curr Alzheimer Res. 2006 Jul;3(3):185-90. doi: 10.2174/156720506777632817.
Other Identifiers
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Allo-20-001
Identifier Type: -
Identifier Source: org_study_id
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