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Alzheimer's DiseasePhase 2NCT00876863

Randomized, Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease

A Phase 2 study testing CERE-110: Adeno-Associated Virus injection Surgery in people with Alzheimer's Disease, run by Sangamo Therapeutics at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment of Alzheimer's disease. CERE-110 is an experimental drug that is designed to help nerve cells in the brain function better. Read more about this study

Who is it for?
Ages 55 to 80 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
CERE-110: Adeno-Associated Virus injection Surgery
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 participants
Where
10 sitesUnited States
Study dates
Nov 2008to 13 Aug 2015
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 55 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of mild to moderate Alzheimer's disease
  • Approved medications for Alzheimer's disease may be taken if the dose has been stable for 3 months
  • A study partner who can attend all study visits
  • Good general health
  • Medically able to undergo neurosurgery

Who cannot join

  • Significant neurological disease other than Alzheimer's disease
  • Significant depression or other psychiatric disorder
  • Unstable medical conditions

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Emory University

    Atlanta, Georgia, 30325

  • University of Alabama

    Birmingham, Alabama, 35294

  • Case Western Reserve University

    Cleveland, Ohio, 44120

  • Duke University

    Durham, North Carolina, 27710

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Medical University of South Carolina

    North Charleston, South Carolina, 29406

  • University of Utah

    Salt Lake City, Utah, 84108

  • University of California, San Diego

    San Diego, California, 92037

  • Georgetown University

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Double-Blind, Placebo-Controlled (Sham Surgery), Randomized, Multicenter Study Evaluating CERE-110 Gene Delivery in Subjects With Mild to Moderate Alzheimer's Disease

The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment of Alzheimer's disease. CERE-110 is an experimental drug that is designed to help nerve cells in the brain function better. CERE-110 uses a virus to transfer a gene that makes Nerve Growth Factor (NGF), a protein that may make nerve cells in the brain healthier and protect them from dying. The virus used in CERE-110 does not cause disease in people. CERE-110 has been carefully studied in laboratory animals and is in the early stages of being tested in people.

Fifty patients with mild to moderate Alzheimer's disease will participate in this study. Half of the study subjects will have CERE-110 injected into the brain during a surgical procedure, while the other half will undergo a "placebo" surgery where no medication will be injected. All study participants will be followed for at least two years after surgery.

Being tested
CERE-110: Adeno-Associated Virus injection Surgery, Placebo Surgery
Keywords
Alzheimer's disease, Dementia, Memory loss, Cognitive impairment, Nerve growth factor, NGF, Neurotrophic factors, Gene therapy
Medical subject headings
Alzheimer Disease, Dementia, Memory Disorders, Cognitive Dysfunction, Hereditary Sensory and Autonomic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CERE-110: Adeno-Associated Virus injection SurgeryDrug

    Injecting CERE-110 2.0 X 10^11 vg into brain during surgical procedure.

  • Placebo SurgeryProcedure or surgery

    Placebo Surgery

Study groups in NCT00876863
Study groupRoleWhat they receive
CERE-110ExperimentalCERE-110: Adeno-Associated Virus Delivery of NGF
Receives: Drug: CERE-110: Adeno-Associated Virus injection Surgery
PlaceboSham comparatorPlacebo Surgery
Receives: Procedure: Placebo Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)

    Measured: 24 Months

Secondary outcomes (4)

  1. Neuropsychological Test Battery

    Measured: 24 Months

  2. Mini-Mental State Examination (MMSE)

    Measured: 24 Months

  3. Neuropsychiatric Inventory (NPI)

    Measured: 24 Months

  4. Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2009 (estimated)
  2. Study startNov 2008
  3. Primary completion13 Aug 2015
  4. Study completion13 Aug 2015

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00876863
Sponsor's protocol ID
CERE-110-03
Other IDs
NIH Grant 1R01AG030048-01A1
Status last verified
Jan 2017
First submitted
3 Apr 2009
Last updated
21 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Jimenez-Maggiora GA, Donohue MC, Rafii MS, Raman R, Aisen PS. Artificial intelligence-enabled safety monitoring in Alzheimer's disease clinical trials. J Prev Alzheimers Dis. 2025 Jan;12(1):100002. doi: 10.1016/j.tjpad.2024.100002. Epub 2025 Jan 1.

    PubMed 39800465

  • Rafii MS, Tuszynski MH, Thomas RG, Barba D, Brewer JB, Rissman RA, Siffert J, Aisen PS; AAV2-NGF Study Team. Adeno-Associated Viral Vector (Serotype 2)-Nerve Growth Factor for Patients With Alzheimer Disease: A Randomized Clinical Trial. JAMA Neurol. 2018 Jul 1;75(7):834-841. doi: 10.1001/jamaneurol.2018.0233.

    PubMed 29582053

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CERE-110: Adeno-Associated Virus injection Surgery in people with Alzheimer's Disease, run by Sangamo Therapeutics at 10 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) (time frame: 24 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00876863, which also lists 2 linked publications.

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 21 Dec 2020.

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