Safety, Tolerability and Efficacy Study to Evaluate Subjects With Mild Cognitive Impairment

What Was Tested

The trial (phase 2) is built around Davunetide.

It had three arms (groups): one (active comparator), one (active comparator) and Placebo (placebo comparator).

Placebo.

The registry classes the interventions as drug.

More on the Plan

Pre-Clinical experiments indicate the AL-108 compound has neuroprotective, cognitive protective and neurotrophic properties; therefore, the compound could be tested in a variety of human diseases.

There are currently no drugs approved for the treatment of MCI nor accepted treatment or standard treatment approach.

Who Took Part

The registry lists 144 actual participants took part.

It was open to people of any sex aged from 55 years up to 85 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Is male or female, at 55-85 years of age (inclusive) at screening. Self-reported memory complaint, corroborated by spouse or companion as appropriate. Wechsler Memory Scale III (WMS-III) age-adjusted Logical Memory II score ≤ 5. Mini-Mental State Exam (MMSE) ≥24. Center for Epidemiologic Studies-Depression (CES-D) score \<27.

The full record lists 10 inclusion and 12 exclusion criteria; among the exclusions: history of alcohol or substance abuse or dependence within the past year; acute infective sinusitis; use of medications that are known to cause frank obtundation of cognition.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Davunetide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Davunetide group and the comparison group ran side by side rather than switching.

As a double-blind Davunetide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2007-01 with completion listed for 2008-01.

It ran at 17 sites in United States (17).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from baseline to Week 12 on the Composite Memory Variable (time frame: 12 weeks).

It also tracked 2 secondary outcomes, for example Changes in the Composite Memory Variable from baseline to weeks 4, 8, and 16 and Changes in test battery individual items from baseline to endpoints (weeks 4, 8, 12, and 16).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Davunetide in 144 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Davunetide compound page, all human trials.