Aim: To examine the efficacy of the combination of galantamine and memantine for the treatment of cognitive deficits in outpatients with schizophrenia. Hypothesis: A combination of galantamine and memantine will improve cognitive impairments in patients with schizophrenia. This is an open-label study to evaluate whether a six week course of galantamine ER and memantine XR is effective in improving the cognitive performance of patients with schizophrenia or schizoaffective disorder. The primary outcome measure will be the change in level of cognition as measured by the MATRICS Consensus Cognitive Battery (MCCB). The results of the MATRICS collaborative project recommended the need for standardized cognitive tests that better distinguish the different facets of cognitive dysfunction in schizophrenia. The MCCB will assess the following seven domains: attention/vigilance, reasoning and problem solving, processing speed, social cognition, verbal learning and memory, visual learning and memory, and working memory. The MCCB will be administered at baseline and at the end of the study. We will report total score and each domain score in the MCCB at baseline and six weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Sheppard Pratt Health System
Baltimore, Maryland, United States
Change in Level of Cognition
The primary outcome measure will be the change in level of cognition as measured by the MATRICS Consensus Cognitive Battery (MCCB). In schizophrenia, usual composite scores are 20-39. In healthy controls, usual composite scores are normalized to 40-60. Higher values of composite scores mean better cognition. Test scores are normalized to healthy controls, therefore no min-max range is available. Final scores calculated by MATRICS Consensus Cognitive Battery software. Exact minimum/maximum are not known to provider. Overall composite scores are reported.
Time frame: Baseline and 6-Weeks
Free Tryptophan (TRP)
The secondary outcome measure will be change in metabolite values. Values were collected in triplicate.
Time frame: Baseline and 6-Weeks
Kynurenic Acid (KYNA)
The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. MS\* AUC is mass spectrometry times area under the curve.
Time frame: Baseline and 6-Weeks
Kynurenine (KYN)
The secondary outcome measure will be change in metabolite values. Values were collected in triplicate.
Time frame: Baseline and 6-Weeks
Picolinic Acid (PIC)
The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. MS\* AUC is mass spectrometry times area under the curve.
Time frame: Baseline and 6-Weeks
KYN/TRP
The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. AUC ratio reported.
Time frame: Baseline and 6-Weeks
KYNA/KYN
The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. AUC ratio reported.
Time frame: Baseline and 6-Weeks
PIC/KYN
The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. AUC ratio reported.
Time frame: Baseline and 6-Weeks
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