anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: Wound infiltration with liposomal bupivacaine

Liposomal bupivacaine: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV

First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine

24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn
Eligibility criteria:
Inclusion Criteria:

Female
ASA physical status 1-3
Scheduled for open abdominal hysterectomy
Age 18-80 years old
Able to participate personally or by legal representative in informed consent in English or Spanish

Exclusion Criteria:

History of relevant drug allergy
Age less than 18 or greater than 80 years
Chronic opioid use or drug abuse
Significant psychiatric disturbance
Inability to understand the study protocol
Refusal to provide written consent
Intervention: Citicoline
Trial phase: Phase 4
ATC code: N06BX06
SMILES: C[N+](C)(C)CCOP(=O)([O-])OP(=O)(O)OC[C@H]1O[C@@H](n2ccc(N)nc2=O)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Citicoline will be started at 500 mg/day at the randomization visit (week 0), then increased to 1000 mg/day at week 2, then 1500 mg/day at week 4, and then 2000 mg/day at week 6 until the end of week 12.
Eligibility criteria:
Inclusion Criteria:

Men and women age 18-75 years old with diagnosis of alcohol dependence
Average alcohol use of at least 28 drinks per week and at least 7 heavy drinking days (defined as 4 or more drinks/day for women, 5 or more drinks/day for men) in the past 28 days
No alcohol use within 72 hours of randomization (maximum abstinence 7 days)
CIWA-Ar (withdrawal scale) score less than or equal to 8 at randomization (consistent with minimal or no withdrawal symptoms and medication probably not needed)

Exclusion Criteria:

Vulnerable populations including individuals with intellectual disability or dementia, prison or jail inmates, pregnant or nursing women, or women of childbearing age who will not use acceptable forms of birth control
History of arrhythmias
Myocardial infarction or coronary artery bypass graft surgery in the past 6 months
Active angina or blood pressure >170/105
High risk for suicide (defined as suicide attempt in past 6 months, or current suicidal ideation with plan and intent)
High risk of violence toward others (defined as assault in past 6 months, or violent thoughts with evidence of plan and intent)
Intensive outpatient treatment for substance abuse (AA, NA meetings or weekly therapy/counseling for substance use for at least 28 days prior to randomization will be allowed)
Dependence (not just abuse) on substances other than alcohol or nicotine
History of delirium tremens or other sever alcohol withdrawal symptoms, history of cirrhosis or AST or ALT >3 times normal, or other unstable medical condition (e.g. uncontrolled diabetes)
History of bipolar disorder or schizophrenia
Current major depressive episode (past episodes and current milder depressive symptoms allowed) or other psychiatric disorder that should be a major focus of treatment
Intervention: Bupivacaine
Trial phase: Phase 3
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 1
Group description: a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).

bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.

Males Single shot peripheral nerve block
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiology (ASA) physical status 1 or 2
Male or female subjects ages 14 to 18 years old at time of procedure
Patients who undergo an ACL repair using the hamstring autograft at The Children's Hospital of Philadelphia
Parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion Criteria:

Parents/patients refusal to the placement of a femoral and/or sciatic nerve block

Contraindications to femoral and/or sciatic nerve block:

Infection
Neurologic deficits, including motor and/or sensory deficit of the femoral and sciatic nerves.
Patients' inability to participate in pain scoring because of developmental delay.
Performance of an all-epiphyseal ACL repair.
Allergy to any of the medications used in the study.
Presence of a coagulopathy
Intervention: Bupivacaine
Trial phase: Phase 3
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 1
Group description: a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).

bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.

Females Single shot peripheral nerve block
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiology (ASA) physical status 1 or 2
Male or female subjects ages 14 to 18 years old at time of procedure
Patients who undergo an ACL repair using the hamstring autograft at The Children's Hospital of Philadelphia
Parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion Criteria:

Parents/patients refusal to the placement of a femoral and/or sciatic nerve block

Contraindications to femoral and/or sciatic nerve block:

Infection
Neurologic deficits, including motor and/or sensory deficit of the femoral and sciatic nerves.
Patients' inability to participate in pain scoring because of developmental delay.
Performance of an all-epiphyseal ACL repair.
Allergy to any of the medications used in the study.
Presence of a coagulopathy
Intervention: Ibuprofen
Trial phase: Phase 4
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 102
Group description: Study group

Ibuprofen: ibuprofen for pain control with dose and frequency 4-10mg/kg/dose. Maximum of 40mg/kg/day, not to exceed 3,200mg/day. Maximum one-time dose of 800mg.
Eligibility criteria:
Inclusion Criteria:

• Male aged 16 years or less or female aged 14 years or less

Open physis on radiographs
Fracture undergoing closed treatment or operative treatment or patient undergoing elective osteotomy

Exclusion Criteria:

• Regular use of NSAIDs

Allergy to NSAIDs
Inability to take breakthrough medications due side effects or allergy
Systemic illness
Renal impairment
Liver disease
Polytrauma
Uncontrolled diabetes
Regular use of corticosteroids
History of any skeletal dysplasia
History of neuromuscular disorder
History of bleeding disorder
History of liver disorder
Pathologic fracture
Closed physes
Male greater than 16 years old
Female greater than 14 years old
Pregnant or possibly pregnant females based on report and last menstrual period
Intervention: Ketorolac
Trial phase: Phase 4
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 240
Group description: Subjects will be administered 10 mg of Ketorolac for pain relief.

10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control.
Eligibility criteria:
Inclusion Criteria:

Severe flank and abdominal pain, severe musculoskeletal pain (traumatic and non-traumatic in origin), headache, dental pain.

Exclusion Criteria:

Age >65, Active Peptic Ulcer disease, Acute Gastrointestinal Hemorrhage, Known Hx of Renal or Hepatic insufficiency, Hx of allergies to NSAIDS.
Intervention: Ketorolac
Trial phase: Phase 4
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 240
Group description: Subjects will be administered 15mg of Ketorolac.

15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.
Eligibility criteria:
Inclusion Criteria:

Severe flank and abdominal pain, severe musculoskeletal pain (traumatic and non-traumatic in origin), headache, dental pain.

Exclusion Criteria:

Age >65, Active Peptic Ulcer disease, Acute Gastrointestinal Hemorrhage, Known Hx of Renal or Hepatic insufficiency, Hx of allergies to NSAIDS.
Intervention: Ketorolac
Trial phase: Phase 4
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 240
Group description: Subject will receive 30mg of Ketorolac as a part of standard care.

30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control.
Eligibility criteria:
Inclusion Criteria:

Severe flank and abdominal pain, severe musculoskeletal pain (traumatic and non-traumatic in origin), headache, dental pain.

Exclusion Criteria:

Age >65, Active Peptic Ulcer disease, Acute Gastrointestinal Hemorrhage, Known Hx of Renal or Hepatic insufficiency, Hx of allergies to NSAIDS.
Intervention: Glucagon
Trial phase: Phase 4
ATC code: H04AA01
SMILES: CSCCC(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CC(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(CCCNC(=N)N)NC(=O)C(CCCNC(=N)N)NC(=O)C(CO)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(CO)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(CC(N)=O)C(=O)NC(C(=O)O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: 1 mg glucagon given during colonoscopy

Glucagon: glucagon (hormone produced by the body)
Eligibility criteria:
Inclusion Criteria:

Any subject who has already been already cleared for and scheduled to undergo colonoscopy at SFGH endoscopy center.

Exclusion Criteria:

Refusal to give informed consent.
Age <18 or >70.
Prior intra-abdominal surgery
Diabetes
Pheochromocytoma
Insulinoma
Liver disease (Child-Pugh Score >6)
Pregnancy
Intervention: Glucagon
Trial phase: Phase 4
ATC code: H04AA01
SMILES: CSCCC(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CC(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(CCCNC(=N)N)NC(=O)C(CCCNC(=N)N)NC(=O)C(CO)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(CO)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(CC(N)=O)C(=O)NC(C(=O)O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: 1 mL normal saline

Placebo
Eligibility criteria:
Inclusion Criteria:

Any subject who has already been already cleared for and scheduled to undergo colonoscopy at SFGH endoscopy center.

Exclusion Criteria:

Refusal to give informed consent.
Age <18 or >70.
Prior intra-abdominal surgery
Diabetes
Pheochromocytoma
Insulinoma
Liver disease (Child-Pugh Score >6)
Pregnancy
Intervention: Ketamine
Trial phase: Phase 2
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Intravenous ketamine 0.5 mg/kg over 40 minutes will be given 6 times over 2 weeks.

Ketamine: IV infusions of 0.5mg/kg of Ketamine hydrochloride over a 40-minute infusion period. Participants will receive a total of 6 doses over a 2-week period.
Eligibility criteria:
Inclusion Criteria:

Male and female adolescents aged 12 to 18 years.
Presence of recurrent major depression without psychotic features confirmed by the Kiddie-Schedule for Affective Disorders and Schizophrenia - Parent and Lifetime Version (Kaufman et al., 1997).
Current depression severity measured by the Children's Depression Rating Scale (CDRS) (Poznanski, 1985) raw score greater than or equal to 36 at screening and the day ketamine is due to be received for the first time.
Current depressive episode resistant to treatment, defined as failure to achieve remission (elimination of symptoms and restoration of pre-morbid psychosocial functioning) from at least 2 antidepressant trials of different pharmacological classes. Systematic evaluation of previous antidepressant trials will be assessed by using the Antidepressant Treatment History Form (Sackeim, 2001).
If present, current antidepressant medication treatment must be dose stable for at least 2 months prior to beginning the study. (Patients will continue with current antidepressant treatment throughout the study. Based on our experience in current research at the VA Medical Center using serial ketamine for adult TRD, patients have shown positive results while continuing their current antidepressant treatment.)

Exclusion Criteria:

Inability to speak English
Inability or unwillingness to provide written informed consent
A history of Mental Retardation or any Pervasive Developmental Disorder
Current or lifetime diagnosis of schizophrenia, schizoaffective disorder, or psychosis Not Otherwise Specified.
Family history with a first degree relative with schizophrenia, schizoaffective disorder, or psychosis Not Otherwise Specified.
Diagnosis of seizures or other neurological disorders.
Comorbid diagnosis of substance abuse or dependence, current or past.
Clinically unstable medical illness.
Current use of the following medications: any barbiturates, any narcotics, any non-benzodiazepine hypnotics at doses higher than zolpidem 10 mg qhs or equivalent for insomnia.
For women: pregnancy (confirmed by baseline lab test).
The presence of any MRI contra-indications such as MRI-incompatible metals in the body or claustrophobia.
Intervention: Progesterone
Trial phase: Not Applicable
ATC code: G03DA04 | G03FA04
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(C)=O)CC[C@@]21[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 34
Group description: 200mg of progesterone suppositories will be administered 3 times a day for 6 days including the day of embryo transfer

vaginal progesterone suppositories: Vaginal Promterium 200 mg , 3 times a day
Eligibility criteria:
Inclusion Criteria:

Female patients in the reproductive age group (18-43 years) undergoing IVF FET cycle, blastocyst stage.

Exclusion Criteria:

History of reaction to either one of the P4 medication
Current use of calcium channels blockers
Uterine factor infertility
Acupuncture therapy during current cycle
Intervention: ASPIRIN
Trial phase: Not Applicable
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 91
Group description: ASA 81 mg. p.o. daily for two months

Acetylsalicylic Acid (ASA): Acetylsalicylic Acid (ASA) 81 mg. oral daily for two months
Eligibility criteria:
Inclusion criteria:

Age greater than 18 years old and less than 50 years old
Uterus and cervix present
Willing to take daily acetylsalicylic acid or HCQ
Willing to undergo pelvic exams
In general good health, no chronic infection and not taking any anti-inflammatory or immunosuppressors
Being HIV negative
Without any cardiovascular disease
Being active in sex work (for the Female commercial sex worker group)

Exclusion criteria:

Age less than 18 years or more than 50 years old
Pregnancy (if a women becomes pregnant during the 10 weeks of the project she will be excluded)
Breast feeding
Pregnant in the last 12 months
Being positive for Sexual transmissible disease or bacterial vaginosis at week 0
Menopausal
No longer involve in sex work (for the female sex worker group)
Having a chronic disease
Taking any of the medication listed in annex 1 for health conditions
Being allergic to acetylsalicylic acid, other medication for pain or fever, tartrazine dye or chloroquine, hydroxuchloroquine, primaquine or any other medication
Having heartburn, stomach pain, stomach ulcer, anemia, hemophilia, kidney or liver disease, psoriasis, porphyria or other blood disease, G-6-PD deficiency, dermatitis (skin inflammation), alcoholism
Having experienced previous vision changes while taking chloroquine, hydroxychloroquine (Aralen) or primaquine.
Having a history of a diagnosed cardiovascular event, heart failure, peripheral arterial disease, angina, stoke, transient ischemic attack
Having a current or recurrent condition with a high risk of major bleeding
Having anemia

Current participation in a clinical trial

-

-
Intervention: Idalopirdine
Trial phase: Phase 3
SMILES: Fc1ccc2c(CCNCc3cccc(OCC(F)(F)C(F)F)c3)c[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1462
Group description: Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
Eligibility criteria:
Inclusion Criteria:

the patient has completed Visit 7 (Completion Visit) in the lead-in double-blind, placebo controlled clinical studies 14861A/NCT01955161 or 14862A/NCT02006641

For patients in the OLEX-MEM:

The patient has completed Visit 6 (Week 28) of the OLEX.
The patient, according to the judgement of the investigator, requires initiation of treatment with memantine as per local label/SmPC/treatment guidelines.

Exclusion Criteria:

The patient has a moderate or severe ongoing adverse event from the lead-in study considered a potential safety risk by the investigator.
The patient has experienced seizures before Completion Visit in the lead-in study.
The patient has evidence of clinically significant disease.
The patient's donepezil treatment is likely to be interrupted or discontinued during the study.
The patient is receiving therapy with another acetylcholinesterase inhibitors (AChEI).

Other protocol-defined inclusion and exclusion criteria may apply.
Intervention: Idalopirdine
Trial phase: Phase 3
SMILES: Fc1ccc2c(CCNCc3cccc(OCC(F)(F)C(F)F)c3)c[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 101
Group description: Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study.
Eligibility criteria:
Inclusion Criteria:

the patient has completed Visit 7 (Completion Visit) in the lead-in double-blind, placebo controlled clinical studies 14861A/NCT01955161 or 14862A/NCT02006641

For patients in the OLEX-MEM:

The patient has completed Visit 6 (Week 28) of the OLEX.
The patient, according to the judgement of the investigator, requires initiation of treatment with memantine as per local label/SmPC/treatment guidelines.

Exclusion Criteria:

The patient has a moderate or severe ongoing adverse event from the lead-in study considered a potential safety risk by the investigator.
The patient has experienced seizures before Completion Visit in the lead-in study.
The patient has evidence of clinically significant disease.
The patient's donepezil treatment is likely to be interrupted or discontinued during the study.
The patient is receiving therapy with another acetylcholinesterase inhibitors (AChEI).

Other protocol-defined inclusion and exclusion criteria may apply.
Intervention: Gadopentetate Dimeglumine
Trial phase: Not Applicable
SMILES: CNCC(O)C(O)C(O)C(O)CO.CNCC(O)C(O)C(O)C(O)CO.O=C([O-])CN(CCN(CC(=O)[O-])CC(=O)O)CCN(CC(=O)[O-])CC(=O)O.[Gd+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.

Magnevist (gadopentetate dimeglumine)
Eligibility criteria:
Inclusion Criteria:

Symptoms and clinical exam consistent with Ménière's disease
Ability to undergo MR exam
Interest in participating in this study
Ability to provide informed consent

Exclusion Criteria:

Children (under age 18),
Contraindication to MR imaging (see attached UCSD MR Screening Form)
Claustrophobia precluding MR exam without sedation
Contraindication to receiving intravenous gadolinium-based contrast agent (see attached UCSD Contrast Policy)
Patients who are pregnant or breast feeding (intravenous contrast agents are Category C)
Contraindication to osmotic challenge (congestive heart failure, renal failure, hepatic failure)
Intervention: Azeliragon
Trial phase: Phase 3
SMILES: CCCCc1nc(-c2ccc(OCCCN(CC)CC)cc2)cn1-c1ccc(Oc2ccc(Cl)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 441
Group description: Azeliragon (TTP488) 5mg orally once daily for 18 months

Parts A and B Combined
Eligibility criteria:
Inclusion Criteria:

Diagnosis of probable Alzheimer Disease (AD) with documented evidence of progression of disease
Mini Mental State Examination (MMSE) score of 21-26, inclusive
Clinical Dementia Rating global score of 0.5 or 1
Rosen-Modified Hachinski Ischemia Score less than or equal to 4
Brain magnetic resonance imaging (MRI) consistent with the diagnosis of probable AD
Concurrent use of cholinesterase inhibitor or memantine with stable dose for at least 3 months prior to randomization
Caregiver willing to participate and be able to attend clinic visits with patient
Ability to ingest oral medications

Exclusion Criteria:

Significant neurological or psychiatric disease other than Alzheimer's disease
Participants with evidence or history of severe drug allergies (resulting in dyspnea or severe rash).
Any contraindications to MRI (e.g., clinically significant claustrophobia, non-removable ferromagnetic implants). Patients with contraindications to MRI may undergo computed tomography (CT) on approval by sponsor.
Any contraindications to the FDG-PET study (e.g. allergy to any component of the FDG dose) in the cohort undergoing a PET scan.
Previous exposure to investigational or non-investigational therapies for Alzheimer's disease within 6 months of screening
History of cancer within the last 5 years except adequately treated cervical carcinoma in-situ, cutaneous basal cell or squamous cell cancer, or non-progressive prostate cancer not requiring treatment
Women of childbearing potential
Uncontrolled blood pressure and/or blood pressure above 160/100
Prescription medical food intended for dietary management of the metabolic processes associated with Alzheimer's disease.
Diagnosis or history of cerebrovascular stroke, severe carotid stenosis, cerebral hemorrhage, intracranial tumor, subarachnoid hemorrhage.
Patients with unstable, uncontrolled diabetes (HbA1c > 7.7%) and those requiring insulin.