## Protocol Section
### Identification Module
**NCT ID:** NCT01129479

**Brief Title:** Galantamine Treatment for Nonfluent Aphasia in Stroke Patients

**Official Title:** Galantamine Treatment for Nonfluent Aphasia in Stroke Patients

#### Organization Study ID Info
**ID:** GAL-EMR-4008
#### Organization
**Class:** OTHER
**Full Name:** University of North Carolina, Chapel Hill
### Status Module
#### Completion Date
**Date:** 2007-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2010-05-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2010-05-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-12

**Type:** ACTUAL

#### Start Date
**Date:** 2004-10

**Status Verified Date:** 2010-05

#### Study First Post Date
**Date:** 2010-05-24
**Type:** ESTIMATED
**Study First Submit Date:** 2010-05-21
**Study First Submit QC Date:** 2010-05-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Ortho-McNeil Neurologics, Inc.

#### Lead Sponsor

**Class:** OTHER

**Name:** University of North Carolina, Chapel Hill

#### Responsible Party

**Old Name Title:** Heidi Roth

**Old Organization:** University of North Carolina

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Cognitive impairment after stroke is common and has a major effect on morbidity and quality of life. Acetylcholinesterase inhibitors have demonstrated benefit in vascular dementia, but efficacy in treating more circumscribed cognitive deficits following stroke, such as aphasia, has not been systematically investigated.

This study evaluated the efficacy of Galantamine (Reminyl) in subjects with chronic, stable non-fluent aphasia secondary to stroke. Subjects enrolled in a double-blind placebo- controlled cross-over study that employed a comprehensive battery of language tests and measures of general cognitive and behavioral status that will be used to control for factors that may influence language functioning. The primary study outcome was a within-subject comparison of changes in language function and behavioral scores between placebo and active-treatment phases (12 weeks each). Our hypothesis was that by increasing acetylcholine levels, and facilitating activity of other neurotransmitters affecting attentional systems, Galantamine would produce gains in both language and behavioral scores in patients suffering chronic effects in cognitive systems due to injury following stroke.

### Conditions Module

**Conditions:**

- Aphasia

- Stroke

**Keywords:**

- Aphasia

- treatment

- cholinesterase inhibitor

- stroke

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 8

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Galantamine

**Label:** Galantamine

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Drug: Placebo pill

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Galantamine

**Description:** Galantamine XL 8 mg for 4 weeks, followed by Galantamine XL 16 mg for subsequent 12 weeks. Taken in the morning with food for total of 12 weeks.

**Name:** Galantamine

**Other Names:**

- Razadyne

- Reminyl

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Placebo pill each morning with food for 12 weeks.

**Name:** Placebo pill

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Analysis of spontaneous speech production with picture description (cookie theft picture): content units and lexical efficiency; as well as Boston Naming Test naming latency.

**Measure:** Spontaneous Speech

**Time Frame:** Every 4 weeks

#### Secondary Outcomes

**Description:** Aphasia Diagnostic Profile: lexical Retrieval, phrase length, phonemic fluency, and category fluency.

**Measure:** ADP

**Time Frame:** Every 4 weeks

**Description:** Subject communication change log scores Caregiver communication change log score

**Measure:** Communication Log scores

**Time Frame:** Every 12 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diagnosis of aphasia with relatively spared comprehension.
* Onset 6 months or greater prior to enrollment.
* Native English speaker
* Right-handed.
* Adults (18 years of age or older).

Exclusion Criteria:

* Patients receiving ongoing individual speech therapy. (Most patients are no longer eligible for individualized speech therapy after 6 months from stroke onset, thus this should not eliminate many patients).
* Extremely mild or extremely severe aphasia. (Boston Naming Test Score \<3 or \>45 items named from 60 items).
* Global dementia (and any other patient with reduced decisional capacity requiring a legally authorized representative for consent).
* Presence of major cognitive deficit other than aphasia caused by stroke related disease.
* Contraindications to cholinomimetic agents: History of active peptic ulcer disease within 1 year, Severe asthma, unstable angina, bradyarrhythmia with resting pulse less than 50, sick sinus syndrome, or seizures.
* Major psychiatric disorders that affect cognition including: psychosis, major depression, bipolar disorder, alcohol or substance abuse.
* Major medical conditions that alter cognition (e.g., heart failure, dialysis dependent renal failure, hepatic failure, active cancer).
* Impairments that affect metabolism of the medication including: Severe renal impairment (Creatinine clearance equal to or greater than 9), and moderate or severe hepatic impairment (Child-Pugh score \>7)
* Patients using medications that have major effects on brain neurotransmitter systems or cognition within 2 months of enrollment. Exclusionary medications are: medications with significant anti-cholinergic activity (tricyclic antidepressants, diphenhydramine), anti-Parkinsonian medications (including Sinemet, amantadine, bromocriptine, pergolide, selegiline), and narcotic analgesics (\> 2 doses per week).

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** University of North Carolina

**Name:** Heidi L Roth, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000013064

- Term: Speech Disorders

- ID: D000007806

- Term: Language Disorders

- ID: D000003147

- Term: Communication Disorders

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M22306

- Name: Stroke

- Relevance: HIGH

- As Found: Stroke

- ID: M4352

- Name: Aphasia

- Relevance: HIGH

- As Found: Aphasia

- ID: M4353

- Name: Aphasia, Broca

- Relevance: HIGH

- As Found: Nonfluent Aphasia

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15864

- Name: Speech Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10823

- Name: Language Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M6374

- Name: Communication Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020521

- Term: Stroke

- ID: D000001037

- Term: Aphasia

- ID: D000001039

- Term: Aphasia, Broca

### Intervention Browse Module - Ancestors

- ID: D000002800

- Term: Cholinesterase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018678

- Term: Cholinergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000010277

- Term: Parasympathomimetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000018697

- Term: Nootropic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: NootAg

- Name: Nootropic Agents

### Intervention Browse Module - Browse Leaves

- ID: M6040

- Name: Cholinesterase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M8820

- Name: Galantamine

- Relevance: HIGH

- As Found: Aortic Valve Replacement

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M20758

- Name: Cholinergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20774

- Name: Nootropic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000005702

- Term: Galantamine

### Misc Info Module

- Version Holder: 2024-05-24
