Alzheimer’s Dementia Studies
1. Dimebon DIM-18 CONCERT - AD study
• Age 50 & Older
• Male or Female
• Diagnosis of Probable Alzheimer’s Dementia (AD)- Mild to Moderate
• Phase III study to determine the safety & efficacy of Dimebon as compared to Placebo in patients that are currently on Aricept (Donepezil)
• Mini Mental Status Score (MMSE) 12-24
• Dimebon 5mg Tid vs. Dimebon 20mg vs. Placebo over 52 weeks
• Must be on Aricept daily for 6 months prior to start of study & at least 10mg 4mths prior to start of study
• 52 Week outpatient study, phase III, Double-Blind Study w/open-label extension (Eligible participants that complete the 52 week study, will be offered to enroll in the open label extension study)
• Must have caregiver to accompany to visits
• Compensation for completed study visits
• Sponsor Medivation, Inc.
2. Dimebon PF-01913539 (Pfizer)-AD Study
• Age 50 & Older
• Male or Female
• Diagnosis of Probable Alzheimer’s Dementia (AD)-Moderate to Severe
• Phase III Safety & Efficacy study of Dimebon in combination with Memantine (Namenda)
• Mini Mental Status Score (MMSE) 5-14
• 50/50 Chance of receiving Dimebon 20mg Tid vs. Placebo
• Must be on Namenda daily for 6 months prior to start of study
• 26 weeks outpatient study- 7 scheduled visits
• At the conclusion of completing the study, participants are eligible for allowed open label Dimebon
• Must have caregiver to accompany to visits
• Compensation for completed study visits
• Sponsor Pfizer
3. Exelon (rivastigmine) Patch (CENA 713-D)-AD study
• Age 50 & older
• Male or Female
• Mini Mental Status Score (MMSE) 3-12
• Diagnosis of Probable Alzheimer’s Dementia (AD)-Severe
• Efficacy study of Exelon (rivastigmine) transdermal patch at higher dose of 15cm2 vs. 5mc2 patch in patients with SEVERE (AD)
• Can stay on Namenda during study as long as they’re on a stable dose for at least 3 months prior to study entry
• 50/50 chance of receiving 15 cm2 vs. 5cm2 patch of Exelon
• No Placebo
• 24-Week study with, 8 scheduled visits
• Patients currently living in nursing home are excluded (assisted living allowed)
• Must have caregiver to accompany to visits
• Compensation for each completed scheduled study visit
• Sponsor Novartis Pharmaceuticals
4. Sonexa (ST101-A001-201)-AD Study
• Age 50 & Older
• Male or Female
• Mini Mental Status Score (MMSE) 12-24
• Diagnosis of Probable Alzheimer’s Dementia (AD)- Mild to Moderate
• Phase II Study to determine the Efficacy, Safety & Tolerability of ST101 in the treatment of AD subjects compared to placebo
• Participants must NOT be on any prescription AD treatment within 60 days of the screening visit & for the duration of the study
• ¼ chance of receiving 30mg of ST101 & 1 placebo tablet, ¼ chance of 90mg tablet of ST101 & 1 placebo tablet, ¼ chance of 2 tablets, 90 mg each, or ¼ chance of 2 placebo
• Approximately 20 weeks (up to 30-days screening visit)
• Must have caregiver to accompany to visits
• Compensation for completed study visits
• Sponsor Sonexa Therapeutics, Inc.
Alzheimer’s Studies
5. Sonexa (ST101-A001-202)/Aricept-AD Study
• Age 50 & Older
• Male or Female
• Mini Mental Status Score (MMSE) 12-24
• Diagnosis of Probable Alzheimer’s Dementia (AD) –Mild to Moderate
• Phase II Study to determine the Efficacy, Safety & Tolerability of ST101 in the treatment of AD subjects concurrently receiving Aricept
• Participants must have been treated with 10mg Aricept, once daily for at least 90 days prior to screening visit & will remain on Aricept throughout the study
• ¼ chance of receiving 10mg of ST101 & 1 placebo tablet, ¼ chance of 60mg tablet of ST101 & 1 placebo tablet, ¼ chance of 2, 60mg tablets, ¼ chance of 2 placebo tablets
• 25 Week outpatient study with, 8 scheduled visits (up to 30-days screening visit)
• Must have caregiver to accompany to visits
• Compensation for completed study visits
• Sponsor Sonexa Therapeutics, Inc.
6. Bapineuzumab (AAB-001, ELN 115727) APoE4 Carriers
• Age 50-89
• Male or female
• Diagnosis of Probable Alzheimer’s Dementia (AD)-Mild to Moderate
• Phase III Efficacy & safety study of Bapineuzumab in patients w/AD who are Apolipoprotein E4 carriers
• Mini Mental Status Score (MMSE) 16-26
• 3/5 chance of receiving .5mg/Kg dose of bapineuzumab infusion vs. 2/5 chance of placebo infusion
• Concurrent treatment w/Cholinesterase inhibitors and/or memantine is allowed if on a stable dose for @ least 120 days prior to screening visit
• Must have caregiver to accompany to visits
• Compensation for completed study visits
• Sponsor Elan Pharmaceuticals, Inc.
7. Bapineuzumab (AAB-001, ELN 115727) APoE4 Non-Carriers
• Age 50-89
• Male of female
• Diagnosis of Probable Alzheimer’s Dementia (AD)-Mild to Moderate
• Phase III Efficacy & safety study of Bapineuzumab in patients with w/ AD who are Apolipoprotein Ee4 (NON-CARRIERS)
• Mini Mental Status Score (MMSE) 16-26
• Double Blind, Multi-Center, randomized study
• 3/10 Chance of receiving 0.5mg/Kg, 3/10 Chance of 1mg/Kg, or 4/10 chances of Placebo Infusions.
• A total of 6 infusions every 13 wks
• 83 Week Study with 15 scheduled visits
• Concurrent treatment with cholinesterase inhibitor and/or memantine is allowed, if on a stable dose for @ least 120 days prior to screening visit
• Must have caregiver to accompany to visits
• Compensation for completed study visits
• Sponsor Elan Pharmaceuticals, Inc.
8) SAM-531/Aricept Study-AD Study
• Age 50 & older
• Male or female
• Diagnosis of Probable Alzheimer’s Dementia (AD)-Mild to Moderate
• Double-Blind, Donepezil (aricept)-referenced, Efficacy & Safety study of 3 dosage levels of SAM-531
• Mini Mental Status Score (MMSE) 12-24
• Phase 2b, multi-center, double Blind,randomized study
• 3/5 chance of dosage levels of SAM-531 (1.5mg, 3mg or 5mg/day) , 1/3 chance of Placebo, or 1/3 chance of Aricept for 24 weeks
• After Week 24, patients who were on the Placebo group will be switched to SAM-531, 5mg for the remaining 28 weeks of the study
• 52-60 Week Study/ 17 study visit
• Participants must NOT be on any AD treatments within 90 days of the baseline visit
• Must have caregiver to accompany to visits
• Compensation for completed study visits
• Sponsor Wyeth Research Division of Wyeth Pharmaceuticals, Inc.
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