search
Back to results

HT-0712 vs. Placebo in Subjects With Age-Associated Memory Impairment (AAMI) (PRIME)

Primary Purpose

Age-Associated Memory Impairment (AAMI)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HT-0712
Placebo
Sponsored by
Dart NeuroScience, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Associated Memory Impairment (AAMI)

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

  • Complaints of memory loss in everyday life
  • Performance at least one standard deviation below the mean established for young adults on standardized memory tests
  • Absence of dementia
  • Intact global intellectual function

Main Exclusion Criteria:

  • Diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's Disease
  • Evidence of dementia
  • Evidence of psychiatric or neurological disorder that could influence cognition or contributed to the subject's memory loss
  • Use of any drugs that could influence cognition

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HT-0712 (50mg)

Placebo

Arm Description

HT-0712 capsules administered once daily.

Placebo capsules administered once daily.

Outcomes

Primary Outcome Measures

Cognitive Drug Research™ (CDR) Study Specific Test Battery

Secondary Outcome Measures

Paired Associated Learning and Memory Test
Subject Global Impression Scale of Cognition (SGI-Cog)

Full Information

First Posted
December 9, 2013
Last Updated
December 1, 2015
Sponsor
Dart NeuroScience, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT02013310
Brief Title
HT-0712 vs. Placebo in Subjects With Age-Associated Memory Impairment (AAMI)
Acronym
PRIME
Official Title
A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing HT-0712 With Placebo in Subjects With Age-Associated Memory Impairment (AAMI)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dart NeuroScience, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase 2 randomized, multicenter, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy of HT-0712 in improving memory and cognitive performance in subjects with Age-Associated Memory Impairment (AAMI)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Associated Memory Impairment (AAMI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HT-0712 (50mg)
Arm Type
Experimental
Arm Description
HT-0712 capsules administered once daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules administered once daily.
Intervention Type
Drug
Intervention Name(s)
HT-0712
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Cognitive Drug Research™ (CDR) Study Specific Test Battery
Time Frame
Weekly over the course of 6-weeks
Secondary Outcome Measure Information:
Title
Paired Associated Learning and Memory Test
Time Frame
Weekly over the course of 6-weeks
Title
Subject Global Impression Scale of Cognition (SGI-Cog)
Time Frame
Weekly over the course of 6-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Complaints of memory loss in everyday life Performance at least one standard deviation below the mean established for young adults on standardized memory tests Absence of dementia Intact global intellectual function Main Exclusion Criteria: Diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's Disease Evidence of dementia Evidence of psychiatric or neurological disorder that could influence cognition or contributed to the subject's memory loss Use of any drugs that could influence cognition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Perera, MD
Organizational Affiliation
Dart NeuroScience, LLC
Official's Role
Study Director
Facility Information:
City
Sun City
State/Province
Arizona
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Santa Monica
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Atlantis
State/Province
Florida
Country
United States
City
Brooksville
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Marlton
State/Province
New Jersey
Country
United States
City
Princeton
State/Province
New Jersey
Country
United States
City
New York
State/Province
New York
Country
United States
City
Dayton
State/Province
Ohio
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Cordova
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States

12. IPD Sharing Statement

Learn more about this trial

HT-0712 vs. Placebo in Subjects With Age-Associated Memory Impairment (AAMI)

We'll reach out to this number within 24 hrs