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

Dart NeuroScience

Status and phase: Completed; Phase 2

Conditions: Age-Associated Memory Impairment (AAMI)

Treatments: Drug: HT-0712; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02013310

HT-0712-201

Details and patient eligibility

About

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)

Enrollment: 119 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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119 participants in 2 patient groups, including a placebo group

HT-0712 (50mg)

Experimental group

Description:

HT-0712 capsules administered once daily.

Treatment:

Drug: HT-0712

Placebo

Placebo Comparator group

Description:

Placebo capsules administered once daily.

Treatment:

Drug: Placebo