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

This study is currently recruiting participants.
Verified April 2017 by Roberta Brinton, University of Southern California
Sponsor:
ClinicalTrials.gov Identifier:
NCT02221622
First Posted: August 20, 2014
Last Update Posted: April 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Roberta Brinton, University of Southern California
July 2, 2014
August 20, 2014
April 20, 2017
August 2014
November 2017   (Final data collection date for primary outcome measure)
Safety and tolerability as measured by vital signs, clinical laboratory measurements, adverse events, brain MRI, clinical assessment and examination. [ Time Frame: From Baseline to Week 16 ]
Same as current
Complete list of historical versions of study NCT02221622 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic profile after single and multiple doses: Maximum Concentration (Cmax) [ Time Frame: Weeks: 1 and 12 ]
  • Pharmacokinetic profile after single and multiple doses: time attain to Cmax (Tmax) [ Time Frame: Weeks: 1 and 12 ]
  • Pharmacokinetic profile after single and multiple doses: Area under the curve (AUC) [ Time Frame: Weeks: 1 and 12 ]
  • Pharmacokinetic profile after single and multiple doses: Drug Clearance (CL) [ Time Frame: Weeks: 1 and 12 ]
  • Pharmacokinetic profile after single and multiple doses: apparent volume of distribution at steady state (Vss) [ Time Frame: Weeks: 1 and 12 ]
  • Cognitive tests (ADAS-Cog; MMSE/MoCA; ADCS-CGIC; CogState) [ Time Frame: Baseline to Week 13 ]
    Alzheimer's disease Assessment Scale Cognitive Subscale 14 (ADAS-Cog); Mini-Mental State Exam (MMSE); Montreal Cognitive Assessment (MoCA); Alzheimer's disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC); CogState 12-min battery (CogState)
  • Structural and functional brain MRI [ Time Frame: Baseline and Week 13 ]
Same as current
Not Provided
Not Provided
 
Allopregnanolone for Mild Cognitive Impairment Due to Alzheimer's Disease or Mild AD
Allopregnanolone Regenerative Therapeutic for MCI/AD: Dose Finding Phase 1
The purpose of this study is to evaluate the safety and tolerability of allopregnanolone, a naturally occurring brain steroid, in mild cognitive impairment and early Alzheimer's disease participants. The primary goal is to determine the maximally tolerated dose.
1) Each dose group will be comprised of 8 participants (6 randomized to allopregnanolone; 2 randomized to placebo) administered one dose of allopregnanolone or placebo once per week for 12 weeks. A higher dose will be administered to the next group of participants when the lower dose is shown to be safe and tolerable. 2) Pharmacokinetic analyses will be conducted on blood samples taken from participants at the beginning and end of the trial. 3) The trial will assess safety including via MRI brain imaging.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Mild Cognitive Impairment
  • Alzheimer Disease
  • Drug: Allopregnanolone injection (intravenous solution)
    Allopregnanolone intravenous infusion
    Other Names:
    • 3α,5α-tetrahydroprogesterone
    • 3α-hydroxy-5α-pregnan-20-one
  • Drug: Placebo injection (intravenous solution)
    Placebo intravenous infusion
  • Experimental: Allopregnanolone 2 mg
    Drug: Allopregnanolone injection (intravenous solution) once per week for 12 weeks
    Intervention: Drug: Allopregnanolone injection (intravenous solution)
  • Experimental: Allopregnanolone 4 mg
    Drug: Allopregnanolone injection (intravenous solution) once per week for 12 weeks
    Intervention: Drug: Allopregnanolone injection (intravenous solution)
  • Experimental: Allopregnanolone 6-18 mg
    Drug: Allopregnanolone injection (intravenous solution) once per week for 12 weeks
    Intervention: Drug: Allopregnanolone injection (intravenous solution)
  • Placebo Comparator: Placebo
    Drug: Placebo injection (intravenous solution) once per week for 12 weeks
    Intervention: Drug: Placebo injection (intravenous solution)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
December 2017
November 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
No
Contact: Gerson Hernandez (323) 865-ALLO (323) 865-2556 gersonhe@usc.edu
Contact: Gerson Hernandez (323) 442-7608 gersonhe@usc.edu
United States
 
 
NCT02221622
AlloPhase1
1UF1AG046148 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Roberta Brinton, University of Southern California
University of Southern California
National Institute on Aging (NIA)
Principal Investigator: Roberta Diaz Brinton, Ph.D. University of Southern California
Principal Investigator: Lon S. Schneider, M.D. University of Southern California
University of Southern California
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP