Acute Intravenous SynaptaminePatient 1 “Before”

Acute Intravenous SynaptaminePatient 1 “After”

Acute Intravenous SynaptaminePatient 2 “Before”

Acute Intravenous SynaptaminePatient 2 “After”

qEEG STUDIES

Subject 1.1: Baseline EEG (Fiq. 1)Baseline EEG analyses shows increased widespread theta (4-8hz) and increased frontal beta (12-25hz) compared to the norm. Widespread increased theta is associated with metabolic disturbance/dysregulation and increased frontal beta is associated with mood disturbance, over-arousal, and anxiety. These features are often associated with anxious, obsessive behaviors, anger, and difficulty de-escalating when upset.  

qEEG STUDIES

Subject 1.1: Post Amino Acid EEG (Fig. 2)Post EEG analyses shows decreased frontal theta (4-8hz) and decreased frontal beta (12-15hz) indicating improved functioning immediately post amino acid intravenous treatment. When individual frequencies are reviewed changes are noted in more detail compared to the norm.    

qEEG STUDIES

BEFORE

AFTER

Subject 1.2: Baseline EEG (Fig. 3)Note increased widespread theta from 4-7 Hz and increased frontal/central beta at 15-16 Hz. 

qEEG STUDIES

Subject 1.2: Post Amino Acid EEG (Fig. 4)Post intravenous amino acid treatment decreased widespread theta at 4-7 Hz and at 15-16 Hz indicating improved functioning. Subject 2: 24 year old male with a history of opiate addiction. Subject was medication and drug free for 30 days prior to the study. Labeling: Subject 2.1 is pre treatment assessment. Subject 2.2 is post treatment of Subject 2.   

qEEG STUDIES

qEEG STUDIES

BEFORE

AFTER

a. P-Values Group 1 vs. Group 2: Week 1

b. P-Values Group 1 vs. Group 2: Week 2

Oral Synaptamine

• In 600 patients, enhancement of cognitive processing, reduction of anxiety, increased concentration, reduction in anger, reduction in depression, increased energy, and reduction in fatigue were observed.(1)

• Claims (Please provide actual data):• Acute IV therapy determined the mechanism of action of

Synaptamine in an alcoholic and heroin abuser whereby existing abnormalities (i.e. widespread theta and widespread alpha activity respectively) during protracted abstinence are “normalized. (2)

• References:• 1 Blum et al. SG839-an amino –acid enkephalinase inhibition

nutraceutical improves recovery of alcoholics. A subtype of RDS . Trends in Applied Sciences Res. 2(2) 132-138, 2007.

• 2 Miller et al. Acute Intravenous Synaptamine Complex [KB220]™ Variant “Normalizes” Abnormal Neurological Activity in Protracted Abstinence of Alcohol and Opiate Patients Using Quantitative Electroencephalographic (QEEG) and Neurotransmitter Genetic Analysis: Pilot Two Case Reports Postgraduate Medicine (in Press).

NEUROIMAGING STUDIESResting–State fMRI After One Dose

Synaptamine (n=5) Placebo (n=5)