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CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease | Clinical Trials | Clareo Health

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

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

NCT00087789•Sangamo Therapeutics

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
•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
+3 more criteria

Exclusion Criteria

•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

Locations (2)

University of California San Diego

San Diego, California, United States

Rush University Medical Center

Chicago, Illinois, United States

Key Dates

Start Date

June 1, 2004

Primary Completion Date

May 1, 2010

Completion Date

May 1, 2010

Last Updated

November 10, 2022

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

CERE-110: Adeno-Associated Virus Delivery of NGF

GENETIC

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 10, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

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