Alzheimer Disease

FDA approval · 2016-11-02

FDA Approved: RIVASTIGMINE — Supplemental Application (Sandoz Inc)

The FDA approved a supplemental application for rivastigmine by Sandoz Inc, updating the approval status of this product.

CLINICAL_TRIALS trial_result · 2016-11-02

Clinical Trial Update: A Study of RO4602522 in Patients With Alzheimer Disease and in Healthy Volunteers [Phase 1]

This document provides an update on a Phase 1 study of RO4602522 in patients with Alzheimer's disease and in healthy volunteers, noting its …

CLINICAL_TRIALS research · 2016-11-02

Clinical Trial Update: A Clinical Trial for an Evaluation of Choline Alfoscerate and Donepezil for Cognitive Improvements of Patients With Cerebrovascular Injury in Alzheimer Patients [Phase 4]

This document provides an update on a Phase 4 clinical trial evaluating choline alfoscerate in combination with donepezil for cognitive impr…

CLINICAL_TRIALS trial_result · 2016-11-01

Clinical Trial Update: Bridging Study of C11 Pittsburgh Compound B (PiB) and F18 Flutemetamol Brain Positron Emission Tomography (PET) [Phase 2]

Phase 2 bridging study of Pittsburgh Compound B and 18F-flutemetamol brain PET imaging in Alzheimer's disease; results posted.

CLINICAL_TRIALS trial_result · 2016-10-27

Clinical Trial Update: fMRI of Vulnerable Brain Regions in Persons at Risk for Alzheimer's Disease

Completed clinical trial update reporting functional MRI findings in brain regions vulnerable to Alzheimer's disease in individuals at risk.

CLINICAL_TRIALS trial_result · 2016-10-19

Clinical Trial Update: Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT) [Phase 3]

Phase 3 Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT) has completed; it evaluated naproxen and celecoxib for preventing Alz…

CLINICAL_TRIALS trial_result · 2016-10-18

Clinical Trial Update: Relative Bioavailability Study in Healthy Subjects to Evaluate the Pharmacokinetics of HTL0009936 After One Dose of Prototype Formulation [Phase 1]

Phase 1 relative bioavailability study in healthy subjects evaluating the pharmacokinetics of HTL0009936 after a single dose of the prototyp…

CLINICAL_TRIALS trial_result · 2016-10-17

Clinical Trial Update: A Single Site, Randomized, Double-blind, Placebo Controlled Trial of NIC5-15 in Subjects With Alzheimer's Disease [Phase 2]

A single-site, randomized, double-blind, placebo-controlled Phase 2 trial of NIC5-15 in Alzheimer's disease completed.

CLINICAL_TRIALS trial_result · 2016-10-14

Clinical Trial Update: The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease [NA]

This clinical trial update assesses the safety and efficacy of long-term treatment with the PINS Stimulator System in patients with Alzheime…

FDA approval · 2016-10-12

FDA Approved: MEMANTINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals LLC)

The FDA approved the original application for memantine hydrochloride from Amneal Pharmaceuticals LLC, granting generic approval for this Al…

CLINICAL_TRIALS trial_result · 2016-10-11

Clinical Trial Update: Cytokines and Cognitive Decline in Alzheimer's Disease [NA]

Completed clinical trial sponsored by Poitiers University Hospital investigating the role of cytokines in cognitive decline in Alzheimer's d…

CLINICAL_TRIALS research · 2016-10-05

Clinical Trial Update: The Study of Mechanism of Alzheimer's Disease Using Acupuncture Based on fMRI [NA]

A clinical trial update examining the mechanism of Alzheimer's disease using acupuncture guided by functional MRI; no results or phase infor…

FDA approval · 2016-10-04

FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Inc.)

FDA approves Alembic Pharmaceuticals Inc.'s supplemental application for Donepezil hydrochloride, a generic product, expanding availability …

FDA approval · 2016-10-04

FDA Approved: DONEPEZIL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

FDA approved a supplemental application for a generic donepezil hydrochloride product from Quallent Pharmaceuticals Health LLC.

FDA approval · 2016-10-04

FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

The FDA approved Sun Pharmaceutical Industries' supplemental application for donepezil hydrochloride, a generic version of Aricept, for the …

FDA approval · 2016-10-04

FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

The FDA approved a supplemental application for donepezil hydrochloride filed by Upsher-Smith Laboratories, LLC. This action concerns a gene…

FDA approval · 2016-10-04

FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (ACI Healthcare USA, Inc.)

The FDA approved a supplemental application for donepezil hydrochloride submitted by ACI Healthcare USA, Inc.

FDA approval · 2016-10-03

FDA Approved: NEURACEQ — Supplemental Application (Lantheus Biosciences Ltd.)

The FDA approved a supplemental application for NEURACEQ (florbetaben F-18) from Lantheus Biosciences Ltd.

FDA approval · 2016-09-28

FDA Approved: MEMANTINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)

The FDA approved the original application for memantine hydrochloride (generic memantine), manufactured by Rising Pharma Holdings, Inc.

FDA approval · 2016-09-28

FDA Approved: MEMANTINE HYDROCHLORIDE — Original Application (Lupin Pharmaceuticals, Inc.)

FDA approved Lupin Pharmaceuticals' memantine hydrochloride as a generic drug (ANDA 206028) for the treatment of moderate to severe Alzheime…