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

NCT ID: NCT02013310

Last Updated: 2015-12-30

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-01-31

Brief Summary

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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)

Detailed Description

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Conditions

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Age-Associated Memory Impairment (AAMI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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HT-0712 (50mg)

HT-0712 capsules administered once daily.

Group Type EXPERIMENTAL

HT-0712

Intervention Type DRUG

Placebo

Placebo capsules administered once daily.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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HT-0712

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dart NeuroScience, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip Perera, MD

Role: STUDY_DIRECTOR

Dart NeuroScience, LLC

Locations

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Sun City, Arizona, United States

Site Status

Long Beach, California, United States

Site Status

Santa Monica, California, United States

Site Status

Denver, Colorado, United States

Site Status

Atlantis, Florida, United States

Site Status

Brooksville, Florida, United States

Site Status

Tampa, Florida, United States

Site Status

Marlton, New Jersey, United States

Site Status

Princeton, New Jersey, United States

Site Status

New York, New York, United States

Site Status

Dayton, Ohio, United States

Site Status

Tulsa, Oklahoma, United States

Site Status

Cordova, Tennessee, United States

Site Status

Austin, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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HT-0712-201

Identifier Type: -

Identifier Source: org_study_id