Alzheimer Disease
Conditions
Keywords
Interventional, Alzheimer, Safety and Tolerability
Brief summary
A 10-week safety and tolerability study of a potential treatment for mild to moderate Alzheimer's disease.
Interventions
DRUGPF-04494700 - Low Dose Arm
30 mg loading dose for 6 days, followed by 10 mg daily
DRUGPF-04494700 - High Dose Arm
60 mg loading dose for 6 days, followed by 20 mg daily
DRUGPlacebo Comparator
Matching placebo.
Sponsors
Trans Tech Pharmaceuticals
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of probably Alzheimer's disease for at least 1 year. * Mini Mental State Exam (MMSE) score between 12-26 at screening. * Participants must be receiving a cholinesterase inhibitor and/or memantine for at least 4 months, and on a stable dose for at least 2 months.
Exclusion criteria
* Current evidence of a neurological or psychiatric illness that could contribute to dementia. * Living alone. * Poorly controlled high blood pressure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Measures include Adverse Events | Every Visit |
| Laboratory Tests | Every Office Visit |
| 12-Lead Electrocardiogram | Every Office Visit |
| 24-Hour 12-Lead Serial ECGs | Baseline, Study End |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive Function Tests: ADAS-Cog, CDR-Sum of Boxes, MMSE, ADCS-ADL | Screening Visit, Baseline, Study End |
| Pharmacokinetic Profile | Baseline and Every Office Visit |
| Surrogate Efficacy Markers in Plasma: A-Beta, C-Reactive Protein, IL-1, IL-6, Isoprostanes, TNF-alpha, TNF-beta | Baseline, Visit 5, Study End |
Countries
United States
Outcome results
None listed