NCT00013650

CompletedPhase 1

Effects of an Anti-Inflammatory Drug in Alzheimer's Disease

National Institute of Mental Health (NIMH)Source

NCT00013650|CompletedPhase 1

Effects of an Anti-Inflammatory Drug in Alzheimer's Disease

Pilot Study of Immunomodulatory Versus Antiinflammatory Therapy in Alzheimer's Disease

National Institute of Mental Health (NIMH)ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

010128

Secondary identifiers

01-M-0128

Study Type

interventional

Reported enrollment (type unavailable)

60

Locations

1 country

Sites

1

Timeline

Study Start

March 22, 2001

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

April 21, 2008

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

The purpose of this study is to evaluate the effects of the drug cyclophosphamide (CY) on inflammation and immune responses in individuals with Alzheimer's Disease (AD). Inflammation and immunologic response appear to contribute to neurodegeneration in people with AD. In a process called gliosis, the brain immune cells microglia and astroglia undergo activation and possible proliferation, which promotes neuronal injury and death. Activated microglia and astroglia produce compounds that are cytotoxic to neurons, and they express molecules that greatly amplify immune and inflammatory processes in the brain. Excessive glial activation and proliferation are thought to be pivotal events that hasten the demise of synapses and neurons in AD. Fortunately, increased understanding of immune and inflammatory pathology in AD has provided new opportunities for designing disease-altering treatments for AD. Studies suggest that medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) and immunomodulatory agents may have an important role in altering the course of AD. CY is a potent anti-inflammatory and immunomodulatory drug that inhibits proliferation of immune cells. This study will evaluate the effects of CY on individuals with mild to moderate AD. Participants in this study will be randomly assigned to receive either two different doses of CY or placebo (an inactive pill) for 6 months. Participants who receive placebo during the 6 months will have the option of receiving CY for an additional 6 months. Participants will undergo magnetic resonance imaging (MRI) scans of the brain. Measures of cerebral spinal fluid biomarkers or neurodegeneration, neuroinflammation, and neuroimmune activation will be taken. In addition, peripheral lymphocyte subsets and peripheral markers of inflammation will be assessed.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 60 participants
Study completion date: April 21, 2008
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 22, 2001
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
March 27, 2001
Actual (reported)
First Posted
March 28, 2001
Actual (reported)
Study Completion
April 21, 2008
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: July 2, 2017
Status Verified: April 21, 2008
Last Update Submitted: June 30, 2017

Conditions

Alzheimer's Disease

Keywords

Alzheimer's DiseaseImmunomodulatoryAntiinflammatoryCyclophosphamideNon-steroidalComplementImmune FunctionImmunotherapy

Interventions

CyclophosphamateDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age50 Years - 95 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects must have a diagnosis of probable Alzheimer's disease according to DSM-IV and NINDS criteria.
Subjects must have mild-moderate severity of dementia according to the Clinical Dementia Rating Scale at the time of study.

Sponsors & Collaborators

National Institute of Mental Health (NIMH)
NIHlead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Related Publications (1)

Aisen PS, Davis KL, Berg JD, Schafer K, Campbell K, Thomas RG, Weiner MF, Farlow MR, Sano M, Grundman M, Thal LJ. A randomized controlled trial of prednisone in Alzheimer's disease. Alzheimer's Disease Cooperative Study. Neurology. 2000 Feb 8;54(3):588-93. doi: 10.1212/wnl.54.3.588.
PMID: 10680787BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type: interventional
Phase: phase 1
Purpose: TREATMENT
Sponsor Type: NIH

Study Record Dates

First Submitted

March 27, 2001

First Posted

March 28, 2001

Study Start

March 22, 2001

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

April 21, 2008

Date type not reported

This date has not been verified as actual or estimated.

They must also have the ability to assign a DPA or have already assigned a DPA and give informed consent for this medication trial and be willing to undergo repeat lumbar punctures for the assessment of cerebrospinal fluid.

You may not qualify if:

Severe dementia (CDR score greater than 2).
Diagnosis of probable vascular dementia.
Inability to give assent for participation or designate a durable power of attorney.
Medication history of cytotoxic drug therapy for more than 2 weeks during the 10 weeks prior to study entry, for more than 10 weeks at any time, or for anytime during the 30 day period prior to study entry.
Recent use of continuous (more than 3 doses per week) nonsteroidal medication (at least one month before entry). Low dose aspirin will not be considered as continuous nonsteroidal anti-inflammatory medication.
Known hypersensitivity to CY, aspirin or any nonsteroidal medication.
Current use of allopurinol, rifampin, methotrexate or warfarin.
Inflammatory conditions (such as SLE, autoimmune disease, etc.) which could respond to medications given in the medication protocol.
Medical conditions including: active or chronic infection requiring antimicrobial therapy, serious viral infection (hepatitis, herpes zoster), a single functioning kidney, renal insufficiency (less than one third of normal GFR), significant hepatic dysfunction, pre-existent malignancy, insulin-treated diabetes mellitus, severe benign prostatic hypertrophy, immunosuppression, myelosuppression, lymphopenia, severe pulmonary dysfunction, history of gastrointestinal ulceration active within the last 5 years, history of gastrointestinal bleeding or perforation, or severe cardiac dysfunction.

Contact the study team to confirm eligibility.

Last Updated

July 2, 2017

Record last verified: 2008-04-21

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00013650
Data provider: ClinicalTrials.gov
Source updated: 2017-07-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:47 UTC

Locations

US(1)

Effects of an Anti-Inflammatory Drug in Alzheimer's Disease

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations