Alzheimer's DiseasePhase 2NCT00174525
Safety Study of Passive Immunization for Patients With Mild to Moderate Alzheimer's Disease
A Phase 2 study testing AAB-001 in people with Alzheimer's Disease, run by Pharmacology Research Institute at 2 sites in United States.
Trial summary
This research study will assess whether AAB-001 is safe, well tolerated and effective for use in patients with Alzheimer's Disease. AAB-001 is a new drug that is not available outside this study. AAB-001 is an antibody (a type of protein usually produced by white blood cells to destroy other substances in the body). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- AAB-001
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Apr 2005to Apr 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Adult, Older adult
Who may be able to join
- Diagnosis of probable AD
- Age from 50 to 85 years, inclusive
- Rosen Modified Hachinski ischemic score less than or equal to 4
- Magnetic Resonance Imaging (MRI) scan consistent with the diagnosis of AD
- Fluency in English
- Stable doses of medications
Who cannot join
- Significant neurological disease other than AD
- Major psychiatric disorder
- Significant systemic illness
- History of stroke or seizure
- Weight greater than 120kg (264 lbs.)
- History of autoimmune disease
Show all 10Show fewer
- Smoking more than 20 cigarettes per day
- Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
- Prior treatment with experimental immunotherapeutics or vaccines for AD
- Presence of pacemakers or foreign metal objects in the eyes, skin, or body
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pharmacology Research Institute
Los Alamitos, California, 90720
Pharmacology Research Institute
Northridge, California, 91324-4625
About this study
Official title: A Phase IIA, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Immunogenicity Trial of AAB-001 in Patients With Mild to Moderate AD
This research study will assess whether AAB-001 is safe, well tolerated and effective for use in patients with Alzheimer's Disease. AAB-001 is a new drug that is not available outside this study. AAB-001 is an antibody (a type of protein usually produced by white blood cells to destroy other substances in the body). In Alzheimer's disease a protein called amyloid gathers in the brain and is thought to cause symptoms like memory loss and confusion. It is hoped that AAB-001 will attach to the amyloid protein in your brain and help your body to remove it.
- Conditions
- Alzheimer's Disease
- Being tested
- AAB-001
- Keywords
- Alzheimer's Caregivers, Alzheimer disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAB-001Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessments
Secondary outcomes (2)
Blood levels of administered study drug
Cognitive and functional assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 2005
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Pharmacology Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Daniel E. Grosz, MD, Principal investigator, Pharmacology Research Institute, Northridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174525
- Sponsor's protocol ID
- PRI#585
- Status last verified
- May 2012
- First submitted
- 9 Sep 2005
- Last updated
- 9 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIA, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Immunogenicity Trial of AAB-001 in Patients With Mild to Moderate AD
- ClinicalTrials.gov ID
- NCT00174525
- Acronym / sponsor ID
- PRI#585
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Caregivers, Alzheimer disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Pharmacology Research InstituteUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Apr 2008
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study will assess whether AAB-001 is safe, well tolerated and effective for use in patients with Alzheimer's Disease. AAB-001 is a new drug that is not available outside this study. AAB-001 is an antibody (a type of protein usually produced by white blood cells to destroy other substances in the body). In Alzheimer's disease a protein called amyloid gathers in the brain and is thought to cause symptoms like memory loss and confusion. It is hoped that AAB-001 will attach to the amyloid protein in your brain and help your body to remove it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of probable AD
- Age from 50 to 85 years, inclusive
- Rosen Modified Hachinski ischemic score less than or equal to 4
- Magnetic Resonance Imaging (MRI) scan consistent with the diagnosis of AD
- Fluency in English
Key exclusion criteria (10 listed)
- Significant neurological disease other than AD
- Major psychiatric disorder
- Significant systemic illness
- History of stroke or seizure
- Weight greater than 120kg (264 lbs.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AAB-001 | Drug | – |
Primary outcome
Safety assessments
2 secondary outcomes
Blood levels of administered study drug
Cognitive and functional assessments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel E. Grosz, MD principal investigator
Pharmacology Research Institute, Northridge
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AAB-001 in people with Alzheimer's Disease, run by Pharmacology Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessments. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2012.