Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
University of Arizona
Study ID
NCT04838301
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Allopregnanolone — DRUG
    Allopregnanolone 4mg IV via 30-minute infusion, once per week.
  • Placebo — OTHER
    Normal saline solution IV via 30-minute infusion, once per week

Study Details

A phase 2, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of Allopregnanolone as a regenerative therapeutic for Alzheimer's disease.

Key Dates

Start date
Aug 15, 2023
Status verified
Mar 2026
Primary completion
Nov 18, 2026
Completion
Mar 18, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Allo group
    Allopregnanolone 4mg IV 30-minute infusion once per week for 6 months.
  • Placebo Comparator: Control group
    Placebo (normal saline) IV 30-minute infusion once per week for 6 months.

Primary Outcome Measure

Hippocampal volume [ Time Frame: Baseline to 6 months ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Perseverance Research CenterScottsdaleArizona85253
Nicole Hank, PhD
4804716132
Allan Block, MD (PRINCIPAL_INVESTIGATOR)
University of Arizona / Clinical & Translational Sciences Research CenterTucsonArizona85721
Faten Sebaali
[email protected]
520-626-3576
Dakota Darby
[email protected]
520-626-4718
David Labiner, MD (PRINCIPAL_INVESTIGATOR)
Firas Kaddouh, MD (SUB_INVESTIGATOR)
ATP Clinical ResearchCosta MesaCalifornia92626
Bobby Shih
714-277-4472
Caitlyn Villanueva
714-277-4472
Gustavo Alva, MD (PRINCIPAL_INVESTIGATOR)
Wake Research-PRI, LLCLos AlamitosCalifornia90720-
Syrentis Clinical ResearchSanta AnaCalifornia92705-
Miami Jewish HealthMiamiFlorida33137
Mariolga Aymat
305-751-8626
Alexander Gomez
305-751-8626
Marc E Agronin, MD (PRINCIPAL_INVESTIGATOR)
Optimus U CorporationMiamiFlorida33135
Yaneicy Gonazalez Rojas, MD
Yaneicy Gonazalez Rojas, MD (PRINCIPAL_INVESTIGATOR)
Combined Research OrlandoOrlandoFlorida32807-
Conquest ResearchWinter ParkFlorida32789
Melissa O'Neill
407-916-0060
Rathod Meera
407-916-0060
Rekha Gandhi, MD (PRINCIPAL_INVESTIGATOR)
MedVadis ResearchWalthamMassachusetts02451
Donald Counihan
781-373-2940
Jessica O'Brien
781-373-2940
David J DiBenedetto, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Perseverance Research Center· Scottsdale, AZUniversity of Arizona / Clinical & Translational Sciences Research Center· Tucson, AZATP Clinical Research· Costa Mesa, CAWake Research-PRI, LLC· Los Alamitos, CASyrentis Clinical Research· Santa Ana, CAMiami Jewish Health· Miami, FL

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