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

NCT00087789 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-11-10

No results posted yet for this study

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.

Conditions

Interventions

GENETIC

CERE-110: Adeno-Associated Virus Delivery of NGF

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

Sponsors & Collaborators

  • Ceregene

    collaborator INDUSTRY

  • Sangamo Therapeutics

    lead INDUSTRY

Principal Investigators

  • Joao Siffert, M.D. · Ceregene

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00087789 on ClinicalTrials.gov