NCT00087789

CompletedPhase 1

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

Sangamo Therapeutics Source

Sangamo Therapeutics

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

CERE-110-01

Study Type

interventional

Actual enrollment (reported)

10

Locations

1 country

Sites

2

Timeline

Study Start

June 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

May 2010

Actual (reported)

Study Completion

May 2010

Actual (reported)

Brief 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. 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.

Registry Overview

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

Recruitment status: completed
Actual enrollment (reported): 10 participants
Study completion date: May 2010
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

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
June 2004
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
July 13, 2004
Actual (reported)
First Posted
July 16, 2004
Actual (reported)
Primary Completion
May 2010
Actual (reported)
Study Completion
May 2010
Actual (reported)

Last Updated: November 10, 2022
Status Verified: October 2016
Last Update Submitted: November 8, 2022

Conditions

Alzheimer's Disease

Keywords

Alzheimer's DiseaseGene Transfer

Outcome Measures

Primary Outcomes (1)

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

Interventions

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

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

Eligibility Criteria

Age50 Years - 80 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Alzheimer's disease as determined by NINCDS/ADRDA criteria.
Score of ≤ 4 on a modified Hachinski Ischemia Scale

Sponsors & Collaborators

Ceregene
Industrycollaborator
Sangamo Therapeutics
Industrylead

Study Sites (2)

University of California San Diego

San Diego, California, 92037, United States

Rush University Medical Center

Chicago, Illinois, 60612, United States

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

Joao Siffert, M.D.
Ceregene
STUDY DIRECTOR

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 13, 2004

First Posted

July 16, 2004

Study Start

June 2004

Date type not reported

This date has not been verified as actual or estimated.

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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

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

You may not qualify if:

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
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

Contact the study team to confirm eligibility.

Primary Completion

May 2010

Actual (reported)

Study Completion

May 2010

Actual (reported)

Last Updated

November 10, 2022

Record last verified: 2016-10

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: NCT00087789
Data provider: ClinicalTrials.gov
Source updated: 2022-11-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:21 UTC

Locations

US(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations