Status and phase
Conditions
Treatments
About
The goal of this clinical trial is to assess the clinical response to a drug combination type of polypill in patients with AD after 180 days of treatment. The anticipated study population are males and females aged 50-85 years with mild to severe Alzheimer's Disease. The duration of individual patient participation will be approximately 224 Days: up to 14 days for Screening, 180 days for study drug administration, and a final follow-up visit at 210 days. The planned study duration is 12-18 months from Screening of the first patient until the last follow-up of the last patients.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Prior diagnosis of mild-to-severe cognitive impairment or probable AD according to the National Institute on Aging and the Alzheimer's Association guidelines by a qualified health practitioner;
History of cognitive and functional decline over at least 1 year that is either documented in medical records or by history from an informant who knows the patient well;
Male or female, age 50 to 85 years (inclusive) at the Screening Visit;
Patient must be ambulatory and reside with a reliable, competent adult (study partner) who meets all applicable guidelines for serving as the patient's legally authorized representative (LAR) and who is able and willing to supervise medication administration and report on the patient's daily activities;
Patient must be able to swallow the study medication (without any alteration to the tablet like crushing, cutting in half, or dissolving in a liquid);
Body weight at screening is ≥40kg;
CDR-SB of 3.0 or higher at Screening Visit;
MMSE-2 ≥8 and≤24 at the Screening Visit;
Patient must be able to understand the nature of the study and have the opportunity to have any questions answered and provide their consent. In the absence of patient's ability to provide informed consent, the informed consent must be obtained from the patient's Legally Authorized Representative (LAR);
For patients receiving an anticholinesterase inhibitor, memantine, or herbal medication for AD, the dose must have been stable for at least 3 months prior to the Screening Visit, and patient must agree to maintain this dose for the duration of the study;
Patients currently treated with a statin must agree to stop their statin therapy for the duration of treatment (180 days);
Creatinine Clearance >30 mL/min at Screening;
Negative HIV and HCV test at Screening;
Complete blood count (CBC), blood chemistry, serum cholesterol, triglycerides, thyroid-stimulating hormone (TSH), and urinalysis, within normal reference ranges or not clinically significant as assessed by the Investigator at Screening;
Physical examination, vital signs, and ECG within normal ranges or not clinically significant as assessed by the Investigator at Screening;
Female patients may participate if they meet 1 of the following criteria:
Note: Patients with persistent menses due to hormonal therapy may participate if a urine pregnancy test (UPT) at the Screening Visit is negative and they agree to continued testing at every study visit.
Male patients must agree to use a barrier method of contraception and refrain from donating sperm for the duration of their participation in the study and for 2 months thereafter.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
206 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
William E Gannon, Jr, MD; Joshua O Atiba, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal