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TerminatedNCT02234752Updated Nov 9, 2017Results posted

Galantamine and Memantine Combination for Cognitive Impairments in Schizophrenia

A Phase 2 interventional study of Galantamine ER and Memantine XR in Schizophrenia and Schizoaffective Disorder, sponsored by Sheppard Pratt Health System. Terminated at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-11-09.

Sponsored by Sheppard Pratt Health System · Phase 2, Interventional, and Treatment

Why this study was terminated
Funding no longer available and PI no longer working at the institution
Phase
Phase 2
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Schizophrenia
  • Schizoaffective Disorder

Keywords

  • Schizophrenia
  • Schizoaffective Disorder
  • Cognition
  • Cognitive Impairment
  • Galantamine
  • Memantine
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 3 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Sheppard Pratt Health System is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Be male or female aged 18 to 55 years (inclusive).
  • Have a DSM-5 diagnosis of schizophrenia or schizoaffective disorder confirmed by medical records. Duration of illness must be ≥ 1year.
  • Be clinically stable for at least two months (i.e., has no more than a "moderately severe" severity rating on the following BPRS items: hallucination, unusual thought content and conceptual disorganization.
  • Have not had a psychiatric hospitalization in the two months prior to screening.
  • Be taking any 1st generation antipsychotic prescribed in the absence of a concomitant anticholinergic or 2nd generation antipsychotic and minimal extrapyramidal symptoms
  • Have a Simpson-Angus Score (SAS) \< 6
  • Be on current medication regimen for at least six weeks before screening at stable dose and frequency for at least 30 days before screening.
  • Be in good general health and expected to complete the clinical study as designed.
  • Subjects of childbearing potential must agree to use two forms of non-hormonal contraception (dual contraception) consistently during the screening and treatment periods of the trial, and for 30 days after the final dose of the study medications.
  • Females of child-bearing potential must have a negative urine pregnancy test at baseline. This may also be done at subsequent visits if subject reports possibility of pregnancy.
  • Have a negative urine drug screen at screening. This may be repeated at the discretion of the primary investigator.
  • Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
  • Be capable of providing informed consent and have voluntarily provided informed consent.

Exclusion criteria

Exclusion Criteria:

  • Have an active, clinically significant unstable medical condition with 30 days prior to screening.
  • Have dementia.
  • Are pregnant, breastfeeding, or planning to become pregnant
  • Are taking or thinking about taking oral contraceptives or an injectable contraceptive.
  • Are taking benztropine at a dose greater than 2 mg daily.
  • Have a history of Pervasive Development Disorder.
  • Have a history of significant head injury/trauma (defined by one of more of the following: loss of consciousness for more than one hour; recurring seizures resulting from the head injury; and/or clear cognitive sequelae of the injury requiring cognitive rehabilitation.)
  • Have an allergy to anticholinesterase medications (galantamine, rivastigimine, donepezil) and memantine
  • Have a DSM-5 diagnosis of alcohol and/or substance use disorder (other than caffeine and tobacco) within the last 6 months.
  • Are taking a restricted medication: Amitriptyline, Doxepin, Imipramine, Flexeril, Clozapine, and/or cortisol (any oral, injectable, or topical steroid medication)
  • Have a history of seizures excluding a childhood febrile seizure
  • Have received ECT within the last three months prior to screening.
  • Have participated in a clinical trial of any other psychotropic medication within last two months prior to screening.
  • Have a "severe" or "extremely severe" severity rating on the BPRS items: hallucination or unusual thought content.
  • Have more than a "moderate" severity rating on the BPRS item conceptual disorganization .
  • Are currently taking 3 or more antipsychotic medications.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Galantamine ER, Memantine XR

    Week 1, Galantamine ER 8 mg HS \& Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS \& Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS \& Memantine XR 21 mg HS

    Drug: Galantamine ER · Drug: Memantine XR

Interventions

  • DrugGalantamine ER

    Also known as: Razadyne, Razadyne ER, Formerly known as Reminyl

  • DrugMemantine XR

    Also known as: Namenda

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Free Tryptophan (TRP)

    The secondary outcome measure will be change in metabolite values. Values were collected in triplicate.

    Time frame: Baseline and 6-Weeks

  2. 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

  3. Kynurenine (KYN)

    The secondary outcome measure will be change in metabolite values. Values were collected in triplicate.

    Time frame: Baseline and 6-Weeks

  4. 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

  5. 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

  6. 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

  7. 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

07

Results

Posted Nov 9, 2017

Participant flow

Participant flow — Overall Study
MilestoneGalantamine ER, Memantine XR
Started3
Completed2
Not completed1

Outcome measures

PrimaryChange 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
Reported as:
Number · units on a scale
Change in Level of Cognition
units on a scaleGalantamine ER, Memantine XR
Baseline Participant 148
Week 6 Participant 148
Baseline Participant 232
Week 6 Participant 225
Baseline Participant 39
SecondaryFree Tryptophan (TRP)

The secondary outcome measure will be change in metabolite values. Values were collected in triplicate.

Time frame:
Baseline and 6-Weeks
Reported as:
Mean · µM
Free Tryptophan (TRP)
µMKP Metabolites Values
Baseline tryptophan Participant 151.94 ± 2.39
Week-6 tryptophan Participant 155.72 ± 2.83
Baseline tryptophan Participant 232.17 ± 1.05
Week-6 tryptophan Participant 224.96 ± 1.33
Baseline tryptophan Participant 335.07 ± 1.22
SecondaryKynurenic 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
Reported as:
Mean · MS* AUC
Kynurenic Acid (KYNA)
MS* AUCKP Metabolites Values
Baseline KYNA Participant 1103911 ± 20870
Week-6 KYNA Participant 183737 ± 25309
Baseline KYNA Participant 295139 ± 36663
Week-6 KYNA Participant 273280 ± 15567
Baseline KYNA Participant 393163 ± 41519
SecondaryKynurenine (KYN)

The secondary outcome measure will be change in metabolite values. Values were collected in triplicate.

Time frame:
Baseline and 6-Weeks
Reported as:
Mean · µM
Kynurenine (KYN)
µMKP Metabolites Values
Baseline KYN Participant 11.62 ± 0.12
Week-6 KYN Participant 11.85 ± 0.24
Baseline KYN Participant 20.86 ± 0.13
Week-6 KYN Participant 20.71 ± 0.05
Baseline KYN Participant 30.76 ± 0.04
SecondaryPicolinic 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
Reported as:
Mean · MS* AUC
Picolinic Acid (PIC)
MS* AUCKP Metabolites Values
Baseline PIC Participant 144021 ± 4470
Week-6 PIC Participant 129542 ± 383
Baseline PIC Participant 281883 ± 7344
Week-6 PIC Participant 263745 ± 1535
Baseline PIC Participant 340189 ± 4342
SecondaryKYN/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
Reported as:
Number · AUC Ratio
KYN/TRP
AUC RatioKP Metabolites Values
Baseline KYN/TRP Participant 11.21
Week-6 KYN/TRP Participant 11.31
Baseline KYN/TRP Participant 21.06
Week-6 KYN/TRP Participant 20.8
Baseline KYN/TRP Participant 30.79
SecondaryKYNA/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
Reported as:
Number · AUC Ratio
KYNA/KYN
AUC RatioKP Metabolites Values
Baseline KYNA/KYN Participant 10.075
Week-6 KYNA/KYN Participant 10.050
Baseline KYNA/KYN Participant 20.121
Week-6 KYNA/KYN Participant 20.114
Baseline KYNA/KYN Participant 30.152
SecondaryPIC/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
Reported as:
Number · AUC Ratio
PIC/KYN
AUC RatioKP Metabolites Values
Baseline PIC/KYN Participant 10.0317
Week-6 PIC/KYN Participant 10.0175
Baseline PIC/KYN Participant 20.1039
Week-6 PIC/KYN Participant 20.0989
Baseline PIC/KYN Participant 30.0655

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Galantamine ER, Memantine XR0/3 (0%)0/3 (0%)1/3 (33.3%)
Most frequent other events
Most frequent other events
EventGalantamine ER, Memantine XR
Increased tirednessGeneral disorders1/3
ConstipationGastrointestinal disorders1/3
DiarrheaGastrointestinal disorders1/3
LightheadednessGeneral disorders1/3
DizzinessGeneral disorders1/3

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Galantamine ER, Memantine XR
<=18 years0
Between 18 and 65 years3
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Galantamine ER, Memantine XR
Female1
Male2
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Galantamine ER, Memantine XR
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American2
White0
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Galantamine ER, Memantine XR
United States3
08

Study locations

1 site
  • Sheppard Pratt Health System
    Baltimore, Maryland 21204, United States
09

References and documents

Publications

  • Koola MM, Buchanan RW, Pillai A, Aitchison KJ, Weinberger DR, Aaronson ST, Dickerson FB. Potential role of the combination of galantamine and memantine to improve cognition in schizophrenia. Schizophr Res. 2014 Aug;157(1-3):84-9. doi: 10.1016/j.schres.2014.04.037. Epub 2014 May 28. PubMed 24878431 ↗
  • Koola MM. Kynurenine pathway and cognitive impairments in schizophrenia: Pharmacogenetics of galantamine and memantine. Schizophr Res Cogn. 2016 Jun;4:4-9. doi: 10.1016/j.scog.2016.02.001. PubMed 27069875 ↗
  • Koola MM, Sklar J, Davis W, Nikiforuk A, Meissen JK, Sawant-Basak A, Aaronson ST, Kozak R. Kynurenine pathway in schizophrenia: Galantamine-memantine combination for cognitive impairments. Schizophr Res. 2018 Mar;193:459-460. doi: 10.1016/j.schres.2017.07.005. Epub 2017 Jul 11. No abstract available. PubMed 28705532 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02234752
Lead sponsor
Sheppard Pratt Health System
Responsible party
Maju Koola (Principal Investigator, Sheppard Pratt Health System) — Principal investigator
First posted
Sep 9, 2014
Start date
Sep 2014
Primary completion
Jul 2016
Completion
Jul 2016
Results posted
Nov 9, 2017
Last update
Nov 9, 2017

Study contacts

Maju M. Koola, MD
principal investigator · Sheppard Pratt Health System

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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