## Protocol Section
### Identification Module
**NCT ID:** NCT00000179

**Brief Title:** Agitation in Alzheimer's Disease

#### Organization Study ID Info
**ID:** IA0003
#### Organization
**Class:** NIH
**Full Name:** National Institute on Aging (NIA)
#### Secondary ID Infos
**ID:** 3U01AG010483-08S2
**Link:** https://reporter.nih.gov/quickSearch/3U01AG010483-08S2
**Type:** NIH
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2005-06-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2005-06-23

**Overall Status:** COMPLETED

**Status Verified Date:** 2005-03

#### Study First Post Date
**Date:** 1999-11-01
**Type:** ESTIMATED
**Study First Submit Date:** 1999-10-29
**Study First Submit QC Date:** 1999-10-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NIH

**Name:** National Institute on Aging (NIA)

### Description Module

**Brief Summary:** Agitation affects 70 to 90 percent of patients with AD. Signs of agitation include verbal and physical aggressiveness, irritability, wandering, and restlessness. These behaviors often make caring for patients at home very difficult. Trazodone and haldol are two of the most commonly prescribed drugs for agitation in AD patients. Behavior management, a non drug approach, has been effective in reducing signs of agitation. Researchers have yet to compare the effectiveness of drug versus non drug therapy to treat agitation in AD patients and determine which is the best treatment. The Alzheimer's Disease Cooperative Study, with funding from the National Institute on Aging, is conducting an agitation treatment program at 21 sites in 16 States. This study will assess which of the above treatments is most effective.

### Conditions Module

**Conditions:**

- Alzheimer Disease

**Keywords:**

- Alzheimer's disease

- Psychomotor agitation

- Behavioral symptoms

- Haloperidol

- Trazodone

- Anti-psychotic agents

- Anti-depressant agents

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

##### Masking Info

**Masking:** DOUBLE

**Primary Purpose:** TREATMENT

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Trazodone

**Type:** DRUG

#### Intervention 2

**Name:** Haloperidol

**Type:** DRUG

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Memory problem consistent with a probable diagnosis of Alzheimer's disease (AD)
* Agitation symptoms for at least the past 2 weeks
* Patient has caregiver who can participate
* Patient lives in the same household as the caregiver

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Los Angeles

**Country:** United States

**Facility:** University of California, Los Angeles

**State:** California

**Zip:** 90095

**Location 2:**

**City:** San Diego

**Country:** United States

**Facility:** University of California, San Diego

**State:** California

**Zip:** 92093-0949

**Location 3:**

**City:** Miami

**Country:** United States

**Facility:** University of Miami

**State:** Florida

**Zip:** 33140

**Location 4:**

**City:** Tampa

**Country:** United States

**Facility:** University of South Florida

**State:** Florida

**Zip:** 33162

**Location 5:**

**City:** Atlanta

**Country:** United States

**Facility:** Emory University

**State:** Georgia

**Zip:** 30329

**Location 6:**

**City:** Springfield

**Country:** United States

**Facility:** Southern Illinois University

**State:** Illinois

**Zip:** 62702

**Location 7:**

**City:** Kansas City

**Country:** United States

**Facility:** University of Kansas Medical Center

**State:** Kansas

**Zip:** 66160

**Location 8:**

**City:** Lexington

**Country:** United States

**Facility:** University of Kentucky

**State:** Kentucky

**Zip:** 40536

**Location 9:**

**City:** Worcester

**Country:** United States

**Facility:** University of Massachusetts

**State:** Massachusetts

**Zip:** 01665

**Location 10:**

**City:** Ann Arbor

**Country:** United States

**Facility:** University of Michigan

**State:** Michigan

**Zip:** 48109

**Location 11:**

**City:** Minneapolis

**Country:** United States

**Facility:** University of Minnesota

**State:** Minnesota

**Zip:** 55455

**Location 12:**

**City:** New York

**Country:** United States

**Facility:** New York University Medical Center

**State:** New York

**Zip:** 10016

**Location 13:**

**City:** New York

**Country:** United States

**Facility:** Mount Sinai Medical Center

**State:** New York

**Zip:** 10029

**Location 14:**

**City:** Rochester

**Country:** United States

**Facility:** University of Rochester

**State:** New York

**Zip:** 14620

**Location 15:**

**City:** Cleveland

**Country:** United States

**Facility:** University Hospitals of Cleveland

**State:** Ohio

**Zip:** 44120

**Location 16:**

**City:** Portland

**Country:** United States

**Facility:** Oregon Health Sciences University

**State:** Oregon

**Zip:** 97201-3098

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, San Diego

**Name:** Leon Thal, MD.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Teri L, Logsdon RG, Peskind E, Raskind M, Weiner MF, Tractenberg RE, Foster NL, Schneider LS, Sano M, Whitehouse P, Tariot P, Mellow AM, Auchus AP, Grundman M, Thomas RG, Schafer K, Thal LJ; Alzheimer's Disease Cooperative Study. Treatment of agitation in AD: a randomized, placebo-controlled clinical trial. Neurology. 2000 Nov 14;55(9):1271-8. doi: 10.1212/wnl.55.9.1271. Erratum In: Neurology 2001 Feb 13;56(3):426.

**PMID:** 11087767

#### See Also Links

**Label:** The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA)

**URL:** http://www.alzheimers.org/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003704

- Term: Dementia

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000024801

- Term: Tauopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M3885

- Name: Alzheimer Disease

- Relevance: HIGH

- As Found: Alzheimer's Disease

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M14452

- Name: Psychomotor Agitation

- Relevance: LOW

- As Found: Unknown

- ID: M6904

- Name: Dementia

- 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: M23002

- Name: Tauopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T2192

- Name: Familial Alzheimer Disease

- Relevance: HIGH

- As Found: Alzheimer's Disease

### Condition Browse Module - Meshes

- ID: D000000544

- Term: Alzheimer Disease

### Intervention Browse Module - Ancestors

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000014150

- Term: Antipsychotic Agents

- ID: D000014149

- Term: Tranquilizing Agents

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000018492

- Term: Dopamine Antagonists

- ID: D000015259

- Term: Dopamine Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018726

- Term: Anti-Dyskinesia Agents

- ID: D000014151

- Term: Anti-Anxiety Agents

- ID: D000017367

- Term: Selective Serotonin Reuptake Inhibitors

- ID: D000014179

- Term: Neurotransmitter Uptake Inhibitors

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000018490

- Term: Serotonin Agents

- ID: D000018687

- Term: Antidepressive Agents, Second-Generation

- ID: D000000928

- Term: Antidepressive Agents

### Intervention Browse Module - Browse Branches

- Abbrev: AnDyAg

- Name: Anti-Dyskinesia Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CaAg

- Name: Cardiotonic Agents

### Intervention Browse Module - Browse Leaves

- ID: M9312

- Name: Haloperidol

- Relevance: HIGH

- As Found: Endometriosis

- ID: M215475

- Name: Haloperidol decanoate

- Relevance: HIGH

- As Found: Endometriosis

- ID: M4247

- Name: Antidepressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M16950

- Name: Trazodone

- Relevance: HIGH

- As Found: PAH

- ID: M16904

- Name: Antipsychotic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: M7473

- Name: Dopamine

- Relevance: LOW

- As Found: Unknown

- ID: M20596

- Name: Dopamine Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M17962

- Name: Dopamine Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M16905

- Name: Anti-Anxiety Agents

- Relevance: LOW

- As Found: Unknown

- ID: M19649

- Name: Selective Serotonin Reuptake Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M15512

- Name: Serotonin

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000006220

- Term: Haloperidol

- ID: C000033563

- Term: Haloperidol decanoate

- ID: D000014196

- Term: Trazodone

### Misc Info Module

- Version Holder: 2024-05-24
