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Alzheimer's DiseasePhase 1NCT00087789

CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease

A Phase 1 study testing CERE-110: Adeno-Associated Virus Delivery of NGF in people with Alzheimer's Disease, run by Sangamo Therapeutics at 2 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

This is a Phase I clinical study to assess the safety, tolerability and biologic activity of in vivo AAV-mediated delivery of CERE-110. Up to 12 subjects will receive open label CERE-110 in dose-escalating fashion. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
CERE-110: Adeno-Associated Virus Delivery of NGF
How many people
10 participants
Where
2 sitesUnited States
Study dates
Jun 2004to May 2010
Phase
Phase 1
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Alzheimer's disease as determined by NINCDS/ADRDA criteria.
  • Score of ≤ 4 on a modified Hachinski Ischemia Scale
  • Mini-Mental State Exam (MMSE) score in the range of 16 to 28, inclusive
  • No significant neurological or medical abnormalities contraindicating surgery, MRI/PET imaging or study participation
  • Subjects stable on standard-of-care medications (i.e., acetylcholinesterase inhibitors) for Alzheimer's disease for 3 months prior to entry
  • A Hamilton Depression Scale score of ≤ 12 on a 17-item scale and no history of major depressive episode within the last 2 years
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  • A score of < 15 on the Beck Depression Inventory
  • Adequate visual and auditory acuity to allow neuropsychological testing
  • Good health with no clinically significant medical or psychological conditions
  • An MRI of the head at screen that is negative for evidence of infection, tumor, infarction or other focal (e.g., subdural hematoma) or generalized lesions(e.g., v hydrocephalus) and without clinical symptoms suggestive of intervening neurological disease
  • Normal serum B12, thyroid function tests, and negative syphilis antibody test
  • The informed consent document must be signed by both:
  • a competent and willing subject, and a surrogate identified by the participant, or a legally authorized power of attorney for Health Care, or a family member

Who cannot join

  • History of cancer within the last five years, except superficial basal or squamous cell skin cancer or cervical carcinoma in situ
  • History of alcohol abuse or dependence within the last two years
  • Liver serum transaminases (AST and/or ALT) > 5 times the upper limit of normal; total and/or direct bilirubin > 1.5 mg/dL, hemoglobin < 9mg/dL; PT and PTT > 2 times the upper limit of normal; creatinine clearance < 30 mL/min; positive serology for HBV or HCV; absolute neutrophil count < 1,500 cells/mm3 and a platelet count < 100,000/mm3
  • Any significant systemic illness, unstable or severe medical condition(s) that could put the subject at risk during the study, interfere with outcome measures or affect compliance with the protocol procedures
  • Centrally active beta-blockers, anti-Parkinsonian medications, psychostimulants, antipsychotics, neuroleptics, or narcotic analgesics, long-acting benzodiazepines or barbiturates, hypertensive agents with a CNS effect, short-acting anxiolytics or sedative hypnotics more frequently than two times per week within 14 days of screening, herbal products for Alzheimer's disease, antidepressants with significant cholinergic side effects (e.g., tricyclics), initiation or change in dose of standard treatment for Alzheimer's disease
  • Other medication with significant cholinergic or anticholinergic side effects
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  • Warfarin (coumadin), nonsteroidal anti-inflammatory drugs, aspirin, Prozac, or Ginkgo biloba within 14 days of surgery
  • Subjects who have received investigational agents or been exposed to investigational devices for 30 days prior to enrollment
  • Subjects with a history of receiving gene transfer products of any kind
  • Subjects who cannot undergo MRI or PET screening

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of California San Diego

    San Diego, California, 92037

Other trials in United States

About this study

Official title: A Phase I, Dose-Escalating Study to Assess the Safety and Tolerability of CERE-110 [Adeno-Associated Virus (AAV)-Based Vector-Mediated Delivery of Beta-Nerve Growth Factor (NGF)] in Subjects With Mild to Moderate Alzheimer's Disease

This is a Phase I clinical study to assess the safety, tolerability and biologic activity of in vivo AAV-mediated delivery of CERE-110. Up to 12 subjects will receive open label CERE-110 in dose-escalating fashion. All subjects will receive bilateral, stereotactic injections of CERE-110 for a total of four (Dose A and B) and six (Dose C) injections to target the basal forebrain region of the brain containing the nucleus basalis of Meynert (NBM). All study participants will be observed for a 24-month period and then followed annually.

Being tested
CERE-110: Adeno-Associated Virus Delivery of NGF
Keywords
Alzheimer's Disease, Gene Transfer
Medical subject headings
Alzheimer Disease

What participants receive

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

  • CERE-110: Adeno-Associated Virus Delivery of NGFGenetic

    CERE-110 2.0 x 10^10 vg, CERE-110 1.0 x 10^11 vg, CERE-110 2.0 x 10^11 vg

What is being measured

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

  1. Safety and tolerability of three different doses of CERE-110 in subjects with mild to moderate Alzheimer's disease

    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 posted16 Jul 2004 (estimated)
  2. Study startJun 2004
  3. Primary completionMay 2010
  4. Study completionMay 2010

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00087789
Sponsor's protocol ID
CERE-110-01
Status last verified
Oct 2016
First submitted
13 Jul 2004
Last updated
10 Nov 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CERE-110: Adeno-Associated Virus Delivery of NGF in people with Alzheimer's Disease, run by Sangamo Therapeutics 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 13 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: finished, as of the sponsor's last update on 10 Nov 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Safety and tolerability of three different doses of CERE-110 in subjects with mild to moderate Alzheimer's disease (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 NCT00087789.

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 10 Nov 2022.

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