Effects of Donepezil HCL on Task-Activated fMRI Brain Activation in Healthy Older Adults at Genetic Risk for Alzheimer's Disease

NeuroTherapia, Inc.

Status and phase: Completed; Phase 4

Conditions: Genetic Risk for Alzheimer's Disease

Treatments: Drug: Placebo; Drug: donepezil HCL

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02087865

14-227

Details and patient eligibility

About

This study examines the sensitivity of functional MRI to detect brain changes caused by donepezil HCL (a cholinesterase inhibitor) in healthy older adults at genetic risk for Alzheimer's Disease.

Full description

This 24-week study will examine the sensitivity of functional MRI to detect brain changes caused by donepezil HCL (a cholinesterase inhibitor) in healthy older adults at genetic risk for Alzheimer's Disease. Participants with a family history of Alzheimer's Disease will be eligible for this study. Participants without a family history of AD will also be enrolled to serve as a control group.

Enrollment: 89 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal general cognitive function
• High Risk Group Only: Family history (1st degree relative) of AD
• Low Risk Group Only: No family history (1st or 2nd degree relative) of AD
• Visual and auditory acuity adequate for neuropsychological testing

Exclusion criteria

• Current or past history of
• neurological illnesses/conditions
• head trauma with significant loss of consciousness
• medical illnesses/conditions that may affect brain function
• severe psychiatric disorder
• substance abuse
• unstable or severe cardiovascular disease or asthmatic condition
• history of stroke or transient ischemic attack

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

89 participants in 3 patient groups, including a placebo group

Donepezil HCL

Active Comparator group

Description:

Participants will receive 5mg of donepezil HCL for 4 weeks and then 10mg of donepezil HCL for 20 weeks.

Treatment:

Drug: donepezil HCL

Placebo

Placebo Comparator group

Description:

Participants will receive placebo for 24 weeks.

Treatment:

Drug: Placebo

Control Group

No Intervention group

Description:

Participants without a family history of AD will undergo the study evaluations but will not receive any study drug