A Multicenter Study of NAP (AL-108) in Schizophrenia

What Was Tested

In this phase 2 trial, researchers set out to test Davunetide.

The TURNS is a NIMH-funded contract for the evaluation of new compounds for the treatment of cognitive impairments in schizophrenia (HHSN 27820044 1003C; P.I.: Steve Marder, M.D.).

Persons with schizophrenia commonly show deficits in a number of areas of cognition that include impairments in attention, memory, and executive functioning (the ability and organize one's behavior).

The registry classes the interventions as drug.

More on the Plan

Background AL-108 is an intranasal drug product containing NAP, an 8 amino-acid peptide (Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln; NAPVSIPQ, MW=824.9) fragment of the much larger (approx. 124KD) Activity-Dependent Neuroprotective Protein (ADNP), which participates in neurodevelopment and neuroprotection.

In mice, ADNP knockouts are lethal exhibiting CNS dysgenesis.

ADNP mediates its effects in part through interaction with microtubules.

Rationale for NAP treatment: tubulin function in brain function The cytoskeleton plays a key role in maintaining the highly asymmetrical shape and structural polarity of neurons that are essential for neuronal physiology.

Who Took Part

Enrollment: 63 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: DSM IV/DSM IV TR diagnosis of schizophrenia. Capable of providing informed consent. Males and Females. Age: 18 and 60. Caucasian or Non Caucasian.

The full record lists 17 inclusion and 13 exclusion criteria; among the exclusions: current treatment with oral conventional antipsychotics (e.g. fluphenazine, haloperidol) or clozapine; loss of consciousness (loc) for more than 1 hour; recurring seizures resulting from the head injury.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Davunetide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Davunetide.

Those kept unaware of assignments: participant and investigator.

It started in 2007-07 with completion listed for 2009-04.

It ran at 8 sites in United States (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in MATRICS Consensus Cognitive Battery Composite Score Change (time frame: Baseline, week 6). Change in MATRICS Consensus Cognitive Battery (MCCB) (time frame: Baseline, 12 weeks).

It also tracked 4 secondary outcomes, for example Change in UCSD Performance-Based Skills Assessment (UPSA) Summary Scores, Change in UCSD Performance-Based Skills Assessment (UPSA) Summary Scores, Change in SCoRS Interviewer Global Rating and Change in SCoRS Interviewer Global Rating.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Davunetide in 63 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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